Recall Z-3138-2026 ยท KDD Kit, Surgical Instrument, Disposable
Windstone Medical Packaging, Inc.
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
| Date | Sep 10, 2026 (initiated Jul 29, 2026) |
| Status | Open, Classified |
| Reason | The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation. |
| Root cause | Equipment maintenance |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated 7/29/26 was sent to customers. AMS requests that you undertake the following activities: 1. Immediately check your inventory for the recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each pack. This sticker will read: RECALL NOTICE BD announced the recall of 70084 PHARMACY NACL .9% 100ML BAG conta |
| Quantity | 3,260 kits |
| Distribution | US Nationwide distribution in the states of CA, GA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.