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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Procedural Trays

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 Class 2 Device Recall Sterile Procedural Trayssee related information
Date Initiated by FirmNovember 17, 2022
Date PostedFebruary 06, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1093-2023
Recall Event ID 91386
Product Classification Hysterectomy kit - Product Code OJF
ProductSterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF
Code Information a. GYN ABD CDS, Item Number: CDS830215G, Case UDI/GTIN: 40889942110040, Unit UDI/GTIN: 10889942110049, Lot Number: 22IMD263; b. LAVH PROCEDURE, Item Number: CDS980754R, Case UDI/GTIN: 40195327008698, Unit UDI/GTIN: 10195327008697, Lot Number: 22JME637; c. TAH CDS, Item Number: CDS982249I, Case UDI/GTIN: 40193489651264, Unit UDI/GTIN: 10193489651263, Lot Number: 22JBM626,22JBK303; d. CUH LITHOTOMY CDS, Item Number: CDS983207M, Case UDI/GTIN: 40195327164608, Unit UDI/GTIN: 10195327164607, Lot Number: 22JBM359; e. LAVH CDS, Item Number: CDS983455C, Case UDI/GTIN: 40193489413114, Unit UDI/GTIN: 10193489413113, Lot Number: 22HBU206,22HBU964; f. GROTH VAGINAL CDS, Item Number: CDS984201T, Case UDI/GTIN: 40195327143986, Unit UDI/GTIN: 10195327143985, Lot Number: 22IBA054; g. MAJOR LITHOTOMY, Item Number: CDS985547N, Case UDI/GTIN: 40193489899925, Unit UDI/GTIN: 10193489899924, Lot Number: 22JBN433,22IBE548; h. MAJOR VAGINAL HARPER PACK-LF, Item Number: DYNJ0161768F, Case UDI/GTIN: 40195327171507, Unit UDI/GTIN: 10195327171506, Lot Number: 22IDC076,22IDA825,22IDA274; i. VAG. HYST TRAY-LF, Item Number: DYNJ0209066N, Case UDI/GTIN: 40889942054429, Unit UDI/GTIN: 10889942054428, Lot Number: 22JME324; j. VAGINAL HYSTERECTOMY PACK-LF, Item Number: DYNJ0373807K, Case UDI/GTIN: 40195327225682, Unit UDI/GTIN: 10195327225681, Lot Number: 22JBO175; k. HYSTERECTOMY PACK-LF, Item Number: DYNJ20485L, Case UDI/GTIN: 40195327024360, Unit UDI/GTIN: 10195327024369, Lot Number: 22IDA372; l. HYSTERECTOMY PACK, Item Number: DYNJ25971I, Case UDI/GTIN: 40888277763525, Unit UDI/GTIN: 10888277763524, Lot Number: 22JBO188; m. MAJOR ABD PROCEDURE PACK-LF, Item Number: DYNJ36731F, Case UDI/GTIN: 40195327148196, Unit UDI/GTIN: 10195327148195, Lot Number: 22IBA619; n. GYN PACK, Item Number: DYNJ40409C, Case UDI/GTIN: 40889942215929, Unit UDI/GTIN: 10889942215928, Lot Number: 22JBM950; o. BLADDER SLING PACK, Item Number: DYNJ43887, Case UDI/GTIN: 40888277073266, Unit UDI/GTIN: 10888277073265, Lot Number: 22JBN288,22IBD109; p. PERI/GYN PACK-RFD, Item Number: DYNJ48918J, Case UDI/GTIN: 40193489729994, Unit UDI/GTIN: 10193489729993, Lot Number: 22JMD314; q. ROBOT HYSTERECTOMY, Item Number: DYNJ49221C, Case UDI/GTIN: 40193489313766, Unit UDI/GTIN: 10193489313765, Lot Number: 22KMA208; r. VAG HYST, Item Number: DYNJ51386B, Case UDI/GTIN: 40193489944229, Unit UDI/GTIN: 10193489944228, Lot Number: 22IBJ500; s. GYN MAJOR PACK, Item Number: DYNJ52095I, Case UDI/GTIN: 40193489996945, Unit UDI/GTIN: 10193489996944, Lot Number: 22IDA203; t. VAGINAL HYSTER PROCEDURE, Item Number: DYNJ53804, Case UDI/GTIN: 40889942444602, Unit UDI/GTIN: 10889942444601, Lot Number: 22JDB955; u. TLH PACK, Item Number: DYNJ63145A, Case UDI/GTIN: 40193489979573, Unit UDI/GTIN: 10193489979572, Lot Number: 22JBN742,22IBK842; v. TLH PACK, Item Number: DYNJ80430, Case UDI/GTIN: 40195327038473, Unit UDI/GTIN: 10195327038472, Lot Number: 22HBN532; w. VAG HYST PACK, Item Number: DYNJ82634, Case UDI/GTIN: 40195327199563, Unit UDI/GTIN: 10195327199562, Lot Number: 22JBY522; x. LITHOTOMY-LF, Item Number: DYNJ900721C, Case UDI/GTIN: 40193489951609, Unit UDI/GTIN: 10193489951608, Lot Number: 22KBC673; y. MAJOR LITHOTOMY, Item Number: DYNJ902373I, Case UDI/GTIN: 40195327224760, Unit UDI/GTIN: 10195327224769, Lot Number: 22JBO747; z. LAVH, Item Number: DYNJ903392F, Case UDI/GTIN: 40193489467506, Unit UDI/GTIN: 10193489467505, Lot Number: 22JBR451; aa. LAVH, Item Number: DYNJ904335B, Case UDI/GTIN: 40193489926720, Unit UDI/GTIN: 10193489926729, Lot Number: 22JBU057; bb. D&C / GYN, Item Number: DYNJ906514B, Case UDI/GTIN: 40193489998567, Unit UDI/GTIN: 10193489998566, Lot Number: 22IBP589,22IBD796; cc. LAPAROSCOPIC HYSTERECTOMY, Item Number: DYNJ906844A, Case UDI/GTIN: 40195327025954, Unit UDI/GTIN: 10195327025953, Lot Number: 22JMG630; dd. FS LAP TUBAL LIGATION, Item Number: DYNJ908306, Case UDI/GTIN: 40195327030316, Unit UDI/GTIN: 10195327030315, Lot Number: 22KBE781,22JBO684; ee. LAVH, Item Number: DYNJQ9041Q, Case UDI/GTIN: 40193489850605, Unit UDI/GTIN: 10193489850604, Lot Number: 22JBG106,22IBB420,22IBC141; ff. ABD HYST PACK-LF, Item Number: DYNJT1912G, Case UDI/GTIN: 40888277809056, Unit UDI/GTIN: 10888277809055, Lot Number: 22HBW646; gg. VAG HYST PK-LF, Item Number: DYNJT1913J, Case UDI/GTIN: 40193489976473, Unit UDI/GTIN: 10193489976472, Lot Number: 22IBQ666,22HBU577
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
886-359-1704
Manufacturer Reason
for Recall		Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
FDA Determined
Cause 2		Device Design
ActionMedline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
Quantity in Commerce1,258 cases (2,154 units)
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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