Windstone Medical Packaging, Inc.: Kit, Surgical Instrument, Disposable
Recall Summary Windstone Medical Packaging is recalling Custom Convenience Kits (Pre Op Kit - NS, Part Number AMS14994) because they contain IV administration sets that B Braun identified as defective. The sets could allow medication to flow backward from secondary IV bags into primary IV bags or connections, or fail to properly prime. The recall affects kits distributed nationwide across all U.S. states.
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
- Reason
- The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-11
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of GA, OR, TN, and WA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b6823187-5b22-4c7a-a7d4-f4e3ff8cbc63