Baxter's elastomeric infusion pumps are non-electronic — Class II medical device recall Z-1677-2013
Terminated recall by Baxter Healthcare Corp., reported 2013-07-17, distributed nationwide. There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged
| Recall number | Z-1677-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2009-07-31 |
| Classified | 2013-07-10 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2016-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CL, CZ, DE, DK, EC, ES, FI, FR, GB, GR, IE, IN, IS, IT, JP, KR, MX, MY, NL, NO, NZ, PA, PT, QA, RU, SA, SG, SI, SK, TH, TR |
| Reason classes | packaging |
| Lot numbers | 08K074, 08K078, 08M014, 08M016, 08M035, 08M036, 08M050, 08M060, 08M063, 08M066, 08N022, 08N041, 08N051, 08N053, 08N074, 09A010, 09A030, 09A032, 09A052, 09A053, 09A057, 09A065, 09A080, 09B006, 09B014, 09B038, 09B044, 09B048, 09B060, 09B063, 09B074, 09C007, 09C016, 09C017, 09C03, 09C041, 09C042, 09C044, 09C053, 09C054 and 20 more |
Product
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.
Reason for recall
There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.