Recall Z-1920-2026 ยท KDD Kit, Surgical Instrument, Disposable
Windstone Medical Packaging, Inc.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
| Date | Apr 22, 2026 (initiated Mar 11, 2026) |
| Status | Open, Classified |
| 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). |
| Root cause | Process control |
| Action | An URGENT: MEDICAL DEVICE CORRECTION notification letter was sent to customers on 3/11/26. AMS requests that you undertake the following activities: 1. Review your inventory for the affected kits, all lots are impacted. 2. Communicate the notification with all personnel that utilize B Braun Admin. Sets contained within AMS kits. 3. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product notification. Your notification to your customers should include a copy of this notification letter. 4. Please complete and return the A |
| Quantity | 380 units |
| Distribution | US Nationwide distribution in the states of GA, OR, TN, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.