Device product
Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.
Z-0681-2019
Product summary
- Event
- Event 81640
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 cases (2,600 sponges)
- Official record key
device-enforcement:Z-0681-2019
Official wording
Reason: Potential compromise of product sterility due to breach of sterile barrier.
Code information: Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111
Distribution pattern: Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.
Derived failure modes
-
Sterility assurance
breach of sterile barrier