Z-0681-2019 Class II Terminated
FDA device recall Z-0681-2019 was initiated by Medical Action Industries Inc on November 27, 2018 and is designated Class II. Reason for recall: Potential compromise of product sterility due to breach of sterile barrier. The recall status is terminated (terminated February 8, 2019). Affected quantity: 13 cases (2,600 sponges).
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