Laparotomy Sponge recall: Sterility Concern
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…
Why was Laparotomy Sponge recalled?
Potential compromise of product sterility due to breach of sterile barrier.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111
- 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…
- Recalling firm
- Medical Action Industries Inc
- Quantity
- 13 cases (2,600 sponges)
- Distribution
- Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.
- Recall date
- January 2, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)