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| Lot Number T26693 |
| Device Problems
Leak/Splash (1354); Nonstandard Device (1420); Material Rupture (1546)
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| Patient Problem
Chemical Exposure (2570)
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Event Type
malfunction
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Manufacturer Narrative
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Response rationale: there were no defects found in inspection of retain samples prelim.Confirmation status: confirmed - capas previously identified.The root cause category is method/other.The attached photo shows the wrap is leaking chemistry from one cell pack.A previous investigation for the same defect, same batch; investigation (b)(4) determined the most probable root cause is method/other.Non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.During this incident, the accumulation of glue (buildup) on dead plates repositioned the web cells in the cross machine direction (mistracking).Therefore, the cells were placed in a different position of the profiled edge exposing the cells to be in direct contact with the die cutter blade.This jeopardized the seal of the perimeter of the cells and allowed the premix to leak from the cut edge of the product.(b)(4) ¿equipment cleaning, inspection and lubrication (cil) procedure¿ includes instructions to clean the m-line critical areas in each production shift.The m-line has a camera system for wraps inspection.This is the line mitigation tool to detect defective wraps and eject them from the line.Cameras 3 & 4 perform 100% inspections (take picture) of the wraps after the wraps are die-cut into discreet products to determine cut cells or if the cells are too close to the edge of the wrap (less than 3 mm).If the wrap was cut with the edge too close to the cell (less than 3 mm) or it has a cut cell the wrap is ejected from the line.When a defective wrap is detected by the cameras its position is recorded by the plc system.Then, the wrap is conveyed throughout the product folding area.Once.
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Event Description
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Event verbatim [preferred term] stuck at work with hot "sand" in my unmentionables [accidental exposure to product], the one i used was faulty and leaking its contents [device leakage].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual) (device lot number t26693, expiration date aug2020) from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient stated, "my day started off rough having my monthly dues, as soon as i could i bought the menstrual wraps and put one to use.Little did i know that the one i used was faulty and leaking its contents.I'm now stuck at work with hot "sand" in my unmentionables.I've honestly never complained about a product to a company before but this is really not cool.I buy these often and i've never had an issue before." the action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Follow-up received from the product quality complaint group on 20jul2018 includes: response rationale: there were no defects found in inspection of retain samples prelim.Confirmation status: confirmed - capas previously identified.The root cause category is method/other.The attached photo shows the wrap is leaking chemistry from one cell pack.A previous investigation for the same defect, same batch; investigation (b)(4) determined the most probable root cause is method/other.Non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.During this incident, the accumulation of glue (buildup) on dead plates repositioned the web cells in the cross machine direction (mistracking).Therefore, the cells were placed in a different position of the profiled edge exposing the cells to be in direct contact with the die cutter blade.This jeopardized the seal of the perimeter of the cells and allowed the premix to leak from the cut edge of the product.(b)(4) "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.The m-line has a camera system for wraps inspection.This is the line mitigation tool to detect defective wraps and eject them from the line.Cameras 3 & 4 perform 100% inspections (take picture) of the wraps after the wraps are die-cut into discreet products to determine cut cells or if the cells are too close to the edge of the wrap (less than 3 mm).If the wrap was cut with the edge too close to the cell (less than 3 mm) or it has a cut cell the wrap is ejected from the line.When a defective wrap is detected by the cameras its position is recorded by the plc system.Then, the wrap is conveyed throughout the product folding area.Once the product is folded it is conveyed to the reject station.The defective wrap identified by the cameras is diverged from the line by a compressed air pneumatic nozzle.The position of the wrap over the conveyor is critical to be ejected from the line when it conveyed from the camera station to the eject point.During a mistracking issue, the position of product conveyed on the line could be changed because the line is susceptible to have jams and many stops and restarts (process variation).Therefore, if the position of the defective wrap is change from the point of the camera station to the eject system an incorrect wrap could be ejected from the line.This is most probable cause of why the defective wrap under this investigation was not ejected from the line.There are seven confirmed complaints for this batch for the subclass of cells damaged/leaking.Two full investigations (b)(4) were completed for the defect.There are no additional actions to be completed at this time.Root cause category (tier 1): method/procedure.Final confirmation status: confirmed - capas known.An evaluation of the complaint history confirms that this is the 11th complaint for the sub class cells damaged/leaking requiring an investigation for this batch.Seven of the previous complaints (b)(4) were confirmed to have a manufacturing related root cause for the complaint of cells damaged/leaking.(b)(4) identified the root cause as equipment category, mechanical failure - the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.(b)(4) identified the root cause as method/other - non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.This complaint investigation is due to a cut cell; during manufacture of the batch accumulation of glue buildup caused the web material to mistrack.The mistrack forced the cells into an incorrect position when the wrap was stamped and the heat cells were cut by the die cutter blade.As a corrective action the cleaning procedures were updated and cleaning of glue build up on the plates identified as critical and completed at the beginning of every shift.Thermacare manufacturing operations employ quality control procedures which include in process testing and visual inspection to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or inspection of retained samples.Additionally, this batch and three others (t26691, t26686 & s68516 menstrual & muscle joint us) were investigated for cells damaged/leaking, the same sub-class but a different cause.The cause was due to a brine solution dosing error where the brine solution prevented proper sealing of the wraps.The brine dosing issue was reviewed by (b)(4) and the outcome determination was to recall four batches (t26691, t26693, t26686 & s68516).The root causes for the brine dosing error and cut cell defects are different.Follow-up (20jul2018 and 19oct2018): this report is being submitted as a reportable device malfunction as investigation results were received from product quality complaint group confirming device malfunction.Company clinical evaluation comment: the above referenced lot number t26693 was recalled on (b)(6) 2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.Comment: the above referenced lot number t26693 was recalled on (b)(6) 2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
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Manufacturer Narrative
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There were no defects found in inspection of retain samples prelim.Confirmation status: confirmed - capas previously identified.The root cause category is method/other.The attached photo shows the wrap is leaking chemistry from one cell pack.A previous investigation for the same defect, same batch; investigation (b)(4)determined the most probable root cause is method/other.Non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.During this incident, the accumulation of glue (buildup) on dead plates repositioned the web cells in the cross machine direction (mistracking).Therefore, the cells were placed in a different position of the profiled edge exposing the cells to be in direct contact with the die cutter blade.This jeopardized the seal of the perimeter of the cells and allowed the premix to leak from the cut edge of the product.Sop-63921 "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.The m-line has a camera system for wraps inspection.This is the line mitigation tool to detect defective wraps and eject them from the line.Cameras 3 & 4 perform 100% inspections (take picture) of the wraps after the wraps are die-cut into discreet products to determine cut cells or if the cells are too close to the edge of the wrap (less than 3 mm).If the wrap was cut with the edge too close to the cell (less than 3 mm) or it has a cut cell the wrap is ejected from the line.When a defective wrap is detected by the cameras its position is recorded by the plc system.Then, the wrap is conveyed throughout the product folding area.Once the product is folde.
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Event Description
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Event verbatim [preferred term] stuck at work with hot "sand" in my unmentionables [accidental exposure to product], the one i used was faulty and leaking its contents [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual) (device lot number t26693, expiration date aug2020) from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient stated, "my day started off rough having my monthly dues, as soon as i could i bought the menstrual wraps and put one to use.Little did i know that the one i used was faulty and leaking its contents.I'm now stuck at work with hot "sand" in my unmentionables.I've honestly never complained about a product to a company before but this is really not cool.I buy these often and i've never had an issue before." action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Additional information received from product quality complaint (pqc) group included investigation results.There were no defects found in inspection of retain samples prelim.Confirmation status: confirmed - capas previously identified.The root cause category is method/other.The attached photo shows the wrap is leaking chemistry from one cell pack.A previous investigation for the same defect, same batch; investigation (b)(4) determined the most probable root cause is method/other.Non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.During this incident, the accumulation of glue (buildup) on dead plates repositioned the web cells in the cross machine direction (mistracking).Therefore, the cells were placed in a different position of the profiled edge exposing the cells to be in direct contact with the die cutter blade.This jeopardized the seal of the perimeter of the cells and allowed the premix to leak from the cut edge of the product.Sop-63921 "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.The m-line has a camera system for wraps inspection.This is the line mitigation tool to detect defective wraps and eject them from the line.Cameras 3 & 4 perform 100% inspections (take picture) of the wraps after the wraps are die-cut into discreet products to determine cut cells or if the cells are too close to the edge of the wrap (less than 3 mm).If the wrap was cut with the edge too close to the cell (less than 3 mm) or it has a cut cell the wrap is ejected from the line.When a defective wrap is detected by the cameras its position is recorded by the plc system.Then, the wrap is conveyed throughout the product folding area.Once the product is folded it is conveyed to the reject station.The defective wrap identified by the cameras is diverged from the line by a compressed air pneumatic nozzle.The position of the wrap over the conveyor is critical to be ejected from the line when it conveyed from the camera station to the eject point.During a mistracking issue, the position of product conveyed on the line could be changed because the line is susceptible to have jams and many stops and restarts (process variation).Therefore, if the position of the defective wrap is change from the point of the camera station to the eject system an incorrect wrap could be ejected from the line.This is most probable cause of why the defective wrap under this investigation was not ejected from the line.There are seven confirmed complaints for this batch for the subclass of cells damaged/leaking.Two full investigations (b)(4) were completed for the defect.There are no additional actions to be completed at this time.Root cause category (tier 1): method/procedure.Final confirmation status: confirmed - capas known.An evaluation of the complaint history confirms that this is the 11th complaint for the sub class cells damaged/leaking requiring an investigation for this batch.Seven of the previous complaints ((b)(4)) were confirmed to have a manufacturing related root cause for the complaint of cells damaged/leaking.(b)(4) identified the root cause as equipment category, mechanical failure the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.(b)(4) identified the root cause as method/other non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.This complaint investigation is due to a cut cell; during manufacture of the batch accumulation of glue buildup caused the web material to mistrack.The mistrack forced the cells into an incorrect position when the wrap was stamped and the heat cells were cut by the die cutter blade.As a corrective action the cleaning procedures were updated and cleaning of glue build up on the plates identified as critical and completed at the beginning of every shift.Thermacare manufacturing operations employ quality control procedures which include in process testing and visual inspection to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or inspection of retained samples.Additionally, this batch and three others (t26691, t26686 & s68516 menstrual & muscle joint us) were investigated for cells damaged/leaking, the same sub-class but a different cause.The cause was due to a brine solution dosing error where the brine solution prevented proper sealing of the wraps.The brine dosing issue was reviewed by pfizer and the outcome determination was to recall four batches (t26691, t26693, t26686 & s68516).The root causes for the brine dosing error and cut cell defects are different.This batch # was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).Follow-up (20jul2018 and 19oct2018): this report is being submitted as a reportable device malfunction as investigation results were received from product quality complaint group confirming device malfunction.Follow-up (19mar2019): follow-up attempts are completed.No further information is expected.Follow-up (17apr2019): new information received from product quality complaint group included: additional product quality investigation results.Company clinical evaluation comment: the above referenced lot number t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020., comment: the above referenced lot number t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
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Manufacturer Narrative
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There were no defects found in inspection of retain samples prelim.Confirmation status: confirmed - capas previously identified.The root cause category is method/other.The attached photo shows the wrap is leaking chemistry from one cell pack.A previous investigation for the same defect, same batch; investigation pr-2206678 determined the most probable root cause is method/other.Non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.During this incident, the accumulation of glue (buildup) on dead plates repositioned the web cells in the cross machine direction (mistracking).Therefore, the cells were placed in a different position of the profiled edge exposing the cells to be in direct contact with the die cutter blade.This jeopardized the seal of the perimeter of the cells and allowed the premix to leak from the cut edge of the product.Sop-63921 "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.The m-line has a camera system for wraps inspection.This is the line mitigation tool to detect defective wraps and eject them from the line.Cameras 3 & 4 perform 100% inspections (take picture) of the wraps after the wraps are die-cut into discreet products to determine cut cells or if the cells are too close to the edge of the wrap (less than 3 mm).If the wrap was cut with the edge too close to the cell (less than 3 mm) or it has a cut cell the wrap is ejected from the line.When a defective wrap is detected by the cameras its position is recorded by the plc system.Then, the wrap is conveyed throughout the product folding area.Once the product is folde.
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Event Description
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Event verbatim [preferred term] stuck at work with hot "sand" in my unmentionables [accidental exposure to product], the one i used was faulty and leaking its contents [device leakage].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual) (device lot number: t26693, expiration date: aug2020) from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient stated, "my day started off rough having my monthly dues, as soon as i could i bought the menstrual wraps and put one to use.Little did i know that the one i used was faulty and leaking its contents.I'm now stuck at work with hot "sand" in my unmentionables.I've honestly never complained about a product to a company before but this is really not cool.I buy these often and i've never had an issue before." action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Additional information received from product quality complaint (pqc) group included investigation results.There were no defects found in inspection of retain samples prelim.Confirmation status: confirmed - capas previously identified.The root cause category is method/other.The attached photo shows the wrap is leaking chemistry from one cell pack.A previous investigation for the same defect, same batch; investigation pr-2206678 determined the most probable root cause is method/other.Non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.During this incident, the accumulation of glue (buildup) on dead plates repositioned the web cells in the cross machine direction (mistracking).Therefore, the cells were placed in a different position of the profiled edge exposing the cells to be in direct contact with the die cutter blade.This jeopardized the seal of the perimeter of the cells and allowed the premix to leak from the cut edge of the product.Sop-63921 "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.The m-line has a camera system for wraps inspection.This is the line mitigation tool to detect defective wraps and eject them from the line.Cameras 3 & 4 perform 100% inspections (take picture) of the wraps after the wraps are die-cut into discreet products to determine cut cells or if the cells are too close to the edge of the wrap (less than 3 mm).If the wrap was cut with the edge too close to the cell (less than 3 mm) or it has a cut cell the wrap is ejected from the line.When a defective wrap is detected by the cameras its position is recorded by the plc system.Then, the wrap is conveyed throughout the product folding area.Once the product is folded it is conveyed to the reject station.The defective wrap identified by the cameras is diverged from the line by a compressed air pneumatic nozzle.The position of the wrap over the conveyor is critical to be ejected from the line when it conveyed from the camera station to the eject point.During a mistracking issue, the position of product conveyed on the line could be changed because the line is susceptible to have jams and many stops and restarts (process variation).Therefore, if the position of the defective wrap is change from the point of the camera station to the eject system an incorrect wrap could be ejected from the line.This is most probable cause of why the defective wrap under this investigation was not ejected from the line.There are seven confirmed complaints for this batch for the subclass of cells damaged/leaking.Two full investigations (b)(4) were completed for the defect.There are no additional actions to be completed at this time.Root cause category (tier 1): method/procedure.Final confirmation status: confirmed - capas known.An evaluation of the complaint history confirms that this is the 11th complaint for the sub class cells damaged/leaking requiring an investigation for this batch.Seven of the previous complaints (b)(4) were confirmed to have a manufacturing related root cause for the complaint of cells damaged/leaking.Pr - 2074034 identified the root cause as equipment category, mechanical failure - the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.Pr - 2206678 identified the root cause as method/other - non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.This complaint investigation is due to a cut cell; during manufacture of the batch accumulation of glue buildup caused the web material to mistrack.The mistrack forced the cells into an incorrect position when the wrap was stamped and the heat cells were cut by the die cutter blade.As a corrective action the cleaning procedures were updated and cleaning of glue build up on the plates identified as critical and completed at the beginning of every shift.Thermacare manufacturing operations employ quality control procedures which include in process testing and visual inspection to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or inspection of retained samples.Additionally, this batch and three others (t26691, t26686 & s68516 menstrual & muscle joint us) were investigated for cells damaged/leaking, the same sub-class but a different cause.The cause was due to a brine solution dosing error where the brine solution prevented proper sealing of the wraps.The brine dosing issue was reviewed by pfizer and the outcome determination was to recall four batches (t26691, t26693, t26686 & s68516).The root causes for the brine dosing error and cut cell defects are different.This batch # was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr 2379610.Additional information received from product quality complaint (pqc) group included investigation results.Investigation summary: the root cause category is method/other.The attached photo shows the wrap is leaking chemistry from one cell pack.This complaint investigation is due to a cut cell; during manufacture of the batch accumulation of glue buildup caused the web material to mistrack.This was investigated in pr-#.The mistrack forced the cells into an incorrect position when the wrap was stamped and the heat cells were cut by the die cutter blade.As a corrective action the cleaning procedures were updated and cleaning of glue build up on the plates identified as critical and completed at the beginning of every shift.This was done as a continuous improvement in sop-# equipment cleaning, inspection and lubrication (cil) procedure, version 6.0, effective 31jan2018.In the revised version of sop-#, the critical cils were highlighted in yellow and now they have priority to be performed first during each manufacturing shift.Thermacare manufacturing operations employ quality control procedures which include in process testing and visual inspection to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or inspection of retained samples.Retained samples met the product description and the product is within expiration date.Additionally, this batch and three others (t26691, t26686 & s68516 menstrual & muscle joint us) were investigated for cells damaged/leaking, the same sub-class but a different cause.The cause was due to a brine solution dosing error where the brine solution prevented proper sealing of the wraps.The brine dosing issue was reviewed by pfizer and the outcome determination was to recall four batches (t26691, t26693, t26686 & s68516).The root causes for the brine dosing error and cut cell defects are different.Investigation pr # t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr #.This is confirmed device malfunction for cell pack damage/ leaking.The severity ranking is s3-skin burn- per rpt-# bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp, effective 28sep2018, version 1.0.Evaluation of the return sample confirmed a device malfunction.There is no further investigation or actions needed.Follow-up (20jul2018 and 19oct2018): this report is being submitted as a reportable device malfunction as investigation results were received from product quality complaint group confirming device malfunction.Follow-up (19mar2019): follow-up attempts are completed.No further information is expected.Follow-up (17apr2019): new information received from product quality complaint group included: additional product quality investigation results.Follow-up (26apr2019 and 29apr2019): new information received from the product quality complaint group includes investigational results.Company clinical evaluation comment: the above referenced lot number: t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020., comment: the above referenced lot number: t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
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Search Alerts/Recalls
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