Recall Z-0681-2019— Medical Action Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medical Action Industries Inc, initiated 2018-11-27, terminated 2019-02-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential compromise of product sterility due to breach of sterile barrier..
- Recalling firm
- Medical Action Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-27
- Terminated
- 2019-02-08
- Firm location
- Arden, NC, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.