Recall Z-0119-2022 ยท NGT Saline, Vascular Access Flush
Windstone Medical Packaging, Inc.
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack
| Date | Aug 19, 2021 |
| Status | Open, Classified |
| Reason | Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe. |
| Root cause | Device Design |
| Action | On 08/19/2021, recall notices were emailed to customers. Customers were asked to do the following: Identify remaining affected kits and follow the over-labeling instructions. The sticker should be placed in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date. Sticker states in part: A recall of the prefilled syringe contained in this kit was announced. All other kit components are not affected. 1. At the time the kit is opened for use any prefilled syringe manufactured by |
| Quantity | 9,378 |
| Distribution | FL and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032438 | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE Tyco Healthcare, Jun 30, 2004 |