Z-0681-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2019
- Initiation Date
- November 27, 2018
- Termination Date
- February 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 cases (2,600 sponges)
Product Description
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.
Reason for Recall
Potential compromise of product sterility due to breach of sterile barrier.
Distribution Pattern
Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.
Code Information
Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111