Windstone Medical Packaging, Inc.: Kit, Surgical Instrument, Disposable
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
- 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/73611112-5699-42dd-a47b-763c8faa3e4c