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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris Pump Infusion Sets

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  Class 1 Device Recall Alaris Pump Infusion Sets see related information
Date Initiated by Firm May 06, 2019
Date Posted July 11, 2019
Recall Status1 Terminated 3 on July 19, 2021
Recall Number Z-1770-2019
Recall Event ID 82752
510(K)Number K894842  
Product Classification Set, administration, intravascular - Product Code FPA
Product Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-0007 2478-0000 C24116E

Infusion sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein.
Code Information Lot Numbers  UDI: 07613203021135- 18096166 18096167 18096235 18096236 18096294 18096295 18096301 19026173 UDI: 07613203015806- 17087410 17087411 18096003 UDI: 07613203021159- 18096803 18096804 UDI: 10885403223204- 18095427 18095428 UDI: 10885403227981- 18096296 18096293 18096273 18096272 18096229 18096228 UDI: 10885403233999- 17087192 17087329 17087330 17087331 18036906 18036907 UDI: 07613203019088- 18116304 UDI: 07613203021234- 18096302 18096422 UDI: 07613203021197- 19025787 UDI: 10885403232305- 18096500 18096501 18096611 UDI: 10885403228001- 18015347 18076591 18076660 UDI: 07613203012713- 17087446 UDI: 07613203012638- 18095286 18095287 18095355 UDI: 07613203012638- 17087336 17087337 17087412 UDI: 10885403226090- 18096312 18096313 18096358 (updated 8/26/19) UDI: 10885403227950- 18096609 18096610 UDI: 07613203021012- 17077279 17077398 17113133 17113134 17118801 17118810 18015266 18015267 18015351 18015353 18015458 18015459 18015568 18026598 18026601 18036759 18036760 18036761 18036941 18036965 18036966 18036967 18037062 18037063 18037064 18075677 18075700 18075709 18075714 18075715 18075716 18076779 18076784 18076830 18086266 18086339 18093065 18093066 18093070 UDI: 07613203021012- 18093076 18093077 18095339 18095354 18095359 18095360 18095412 18095889 18095980 18095991 18095996 18096179 18096180 18115088 18115135 18116622 18116623 18116624 18116707 19013154 19013155 19023000 19026122 19026123 19026211 19033033 UDI: 07613203012430- 17077358 17113141 17113142 17113146 18023014 18076737 18076738 18076739 18076740 18076741 18086332 18086333 18086334 18093055 18093056 18093057 18093072 18093073 18093074 18093075 18095068 18095357 18095358 18095417 18116640 18116641 18116703 19026180 19026215 19026262 UDI: 07613203019149- 18096445 UDI: 10885403227998- 17077131 17077313 17087341 17125017 18015417 18015453 18015454 18026723 18026724 18026754 18036897 18075724 18076609 18076610 18076611 18086142 18086230 18086259 18086330 18095280 18115006 18115007 18115132 18116575 18116635 18116647 18116648 18116657 18116658 18116659 18116754 18116755 18116762 19026002 19026003 17077013 17077267 17077268 18015449 18015450 18023011 18023012 18023013 18026479 18026729 18026731 18026732 18036894 18036995 UDI: 07613203020992- 18037027 18037029 18037048 18037051 18076650 18076675 18076676 18086146 18095276 18095352 18115003 18115004 18115129 19013152 19013153 19023004 19023005 UDI: 10885403228018- 18095992 18095998 18096112 18096113 18096314 UDI: 10885403227974- 18096269 18096271 UDI: 07613203011310- 18015339 18036908 18115199 18115200 UDI: 07613203019460- 18116521 18116637 18116638 18116751 18116752 UDI: 10885403235122- 17087193 17087334 18116061 18116062 UDI: 07613203021098- 18096030 18096110  Updated 8/26/19 - All product model codes with expiration dates between and including 05/2019 and 08/2020 (manufactured between and including 05/2016 and 08/2017): 10010453 10010454 10010483 10010541 10010761 10010871 10011301 10011462 10012144 10012182 10012283 10012293 10012645 10013034 10013037 10013072 10013186 10013361 10013361T 10013854 10013889 10013890 10014035 10014855A 10015012 10015294 10015312 10015414 10015489 10015645 10015861A 10015862 10015896 10031773 10061661A 10062818 10074281A 10137405 10142568 10178573 10321213 10321213T 10382963 10404198 10406194 10408730 10561554 10779313 10813621 10817613 10817920 10821753 10863358 10879047 10879391 10927766 10933805 10934345 10942011 11045328 11059729 11063735 11118122 11130148 11133698 11147991 11171447 11258588 11287205 11401542 11404930 11419365 11426964 11426965 11484001 11522558 11532269 11582773 11590100 11607704 11607787 11609481 11612593 11613191 2107-0500 2110-0500 2111-0500 2120-0007 2120-0500 2122-0007 2123-0007 2125-0500 2126-0007 2126-0500 2129-0500 2130-0500 2131-0500 2140-0600 2141-0600 2171-0007 2177-0000 2200-0500 22000-B007T 2202-0007 2202-0500 2203-0500 2204-0007 2205-0000 2206-0007 2207-0007 2210-0500 2211-0500 2220-0500 2232-0007 22600-0007T 2260-0500 22601-B007T 22602-B007T 22603-B007T 2270-0500 2278-0500 2280-0000 2280-0006 2280-0008 24001-0007 24008-0007 24010-0007T 2401-0500 2403-0000 2403-0007 2406-0500 2408-0500 2409-0500 2410-0500 2411-0500 2412-0500 2413-0007 2414-0500 2416-0007 2419-0007 2420-0007 2420-0500 2421-0500 2422-0007 2423-0007 2424-0007 2425-0500 2426-0007 2426-0500 2428-0007 2429-0007 2429-0500 2430-0500 24301-0007T 2432-0007 2433-0007 2434-0007 2435-0007 2436-0500 2440-0600 2441-0007 2441-0600 2442-0007 2443-0600 2444-0007 2447-0007 2447-0600 2448-0007 2448-0600 2449-0600 2450-0500 2451-0007 2452-0007 2455-0500 24601-B007T 2461-0007 2463-0007 2465-0007 2466-0007 2477-0000 2477-0007 2478-0000 2929-0500 2941-0500 2942-0500 C24101E C24103E C24104E C24105E C24106E C24107E C24111E C24112 C24116E C24117 10010541-07 10074281 11147992 2438-0500 24600-0007 C24119E
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
201-847-6800
Manufacturer Reason
for Recall		 An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, BD, sent "Urgent Medical Device Recall" letters dated 5/6/19 to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately review your inventory for the specific model codes and lot numbers listed in the Affected Product Table. Destroy all product subject to the recall based on the affected product table -following your institutions process for destruction. 2. BD is instructing customers to discard all model codes and lot numbers with an expiration date between and including 05/2019 and 08/2020 in addition to the Affected Product List in this communication. 3. Share the recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 4. Until all affected product has been discarded and is no longer in use, please follow the instruction below: ¿ During infusion of critical medications, check the medication bag more frequently than normal to ensure that the remaining volume corresponds to the expected delivery time. 5. As always, review and follow the Instructions for Use provided with the product and the Alaris System, which includes the following: ¿ After the infusion set is loaded into the pump with the door closed, open the roller clamp and verify that no fluid is dripping through the drip chamber. If drips are observed, do not initiate infusion with the Pump Module unit and infusion set. ¿ Ensure that the clamp on the Alaris Pump Module Infusion Set is closed whenever infusion is not intended. 6. Any case of over-infusion or other serious or unexpected medical device incidents in patients receiving infusions with these Infusion Sets should be reported to Becton Dickinson. When reporting, please identify the model code and lot number to aid in the investigation process. 7. Complete the attached Customer Response Form and return to the BD contact noted on the form whether you have any of the impacted
Quantity in Commerce 17992 lots of Infusion Sets totaling 183,572,651 units (Updated 8/26/19)
Distribution Worldwide Distribution; US (nationwide distribution) to following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, ID, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico; and countries of: Australia, Belgium, Canada, Chile, Malaysia, Mexico, Panama, Singapore and Taiwan.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = IMED CORP.
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