Medtronic Lamicel Sponges Recalled for Sterilization Dose Deficiency
Medtronic Xomed is recalling Lamicel 20PK 5MM INTL sponges because the routine sterilization dose does not meet the required Sterility Assurance Level.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential sterility failures in medical devices.
Plain-English summary
Medtronic Xomed, Inc. is recalling Lamicel 20PK 5MM INTL sponges. The recall involves 307 packs, totaling 6,140 units. The affected product was distributed only in Japan.
The reason for the recall is that the routine sterilization dose does not meet the required Sterility Assurance Level. This deficiency means the sterilization process may not have been sufficient to ensure the sponges are sterile.
The affected lots are 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, and 9712918. The UDI for the product is 20885074749055. Healthcare providers and facilities in Japan should check their inventory for these specific lot numbers and stop using the affected sponges.
The recalled product
- Product
- Lamicel 20PK 5MM INTL
- Manufacturer
- Medtronic Xomed, Inc.
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 (12)
- UDI: 20885074749055
- SPONGE 2203-501EX LAMICEL 20PK 5MM INTL
- 2203-501EX
- Lots 9642542
- 9657414
- 9657415
- 9657416
- 9677915
- 9707331
- 9707338
- 9707334
- 9712918
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Medtronic Xomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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