Recall Z-1068-2019— Medical Action Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medical Action Industries Inc, initiated 2019-03-01, terminated 2021-04-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap 4X18 XR (5 each/pack, 40 pack/case) - Model Number 407; 5. Lap 12X12 XR (5 each/pack, 40 pack/case) - Model Number 411; 6. Lap 12X12 XR w/ring (5 each/pack, 40 pack/case) - Model Number 412; 7. Lap 8X36 XR (5 each/pack, 40 pack/case) - Model Number 419; 8. Lap 17X26 XR (5 each/pack, 20 pack/case) - Model Number 426;. Reason: Potential lack of sterility assurance.
- Recalling firm
- Medical Action Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-01
- Terminated
- 2021-04-06
- Firm location
- Arden, NC, United States
Product description
Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap 4X18 XR (5 each/pack, 40 pack/case) - Model Number 407; 5. Lap 12X12 XR (5 each/pack, 40 pack/case) - Model Number 411; 6. Lap 12X12 XR w/ring (5 each/pack, 40 pack/case) - Model Number 412; 7. Lap 8X36 XR (5 each/pack, 40 pack/case) - Model Number 419; 8. Lap 17X26 XR (5 each/pack, 20 pack/case) - Model Number 426;
Reason for recall
Potential lack of sterility assurance
Data sourced from openFDA. This site is unofficial and independent of the FDA.