Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Concerns
Medical Action Industries is recalling specific lots of laparotomy sponges due to a potential lack of sterility assurance. The affected products were distributed nationwide and to Canada and Saudi Arabia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential lack of sterility assurance in a medical device, which poses a risk of harm even though no injuries have been reported.
Plain-English summary
Medical Action Industries Inc is recalling specific model numbers of Laparotomy Sponges. The recall is due to a potential lack of sterility assurance in the affected products. The recall covers 228,300 packs, with each pack containing 5 units.
The affected products include various sizes and configurations of laparotomy sponges, such as Lap 18X18 XR, Lap 4X18 XR, and Lap 12X12 XR. Specific lot numbers and expiration dates are listed in the agency's recall record. The products were distributed nationwide to numerous US states, as well as to Canada and Saudi Arabia.
Healthcare facilities and consumers should check their inventory for the specific model numbers and lot numbers listed in the recall. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- 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
- Manufacturer
- Medical Action Industries Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Model Number (Lot Number
- Expiration Date): 300 (000252968
- 11/08/2022)
- 450 (1808JK318A
- 08/30/2023)
- 450 (1807JK318A
- 07/20/2023)
- SM40018 (1807JK323A
- V300 (0000253083
- 11/12/2022)
- 2. Model Number (Lot Number
- Expiration Date): 400 (1808JK301B
- 400 (1807JK301A
- 404 (1808JK306A
- 08/20/2023)
- V400 (1807JK319A
- V450 (1808JK320A
- V450 (1808JK320B
- 3. Model Number (Lot Number
- Expiration Date): 402 (1808JK304B
Distribution
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