FDA Recalls Sterile Surgical Kits with Compromised Gloves
The FDA is recalling 4,136 sterile surgical kits because the Devon Light Gloves inside contain splits or holes that compromise sterility.
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, and the hazard involves compromised sterility in surgical kits, which poses a significant risk of infection or serious injury to patients.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 4,136 sterile ASC (Breast) Kits manufactured by Covidien LLC. The recall is due to the presence of splits or holes in the Devon Light Gloves contained within the kits, which compromises the sterility of the product.
The affected products include specific catalog numbers: 573328 (7437-NRF SURGICAL ASC KIT), 50000511 (7516-UNI Universal ASC Kit), 50000512 (7557-UNI Universal ASC Kit), and 50000515 (7667-BRT Breast ASC Kit). The recall applies to lots where the lot number begins with 508xxxx or lower.
These kits were distributed worldwide, including the United States (nationwide, including the Virgin Islands), Canada, Australia, New Zealand, and numerous countries in Europe, the Middle East, Africa, and Asia. Healthcare facilities and consumers should stop using these kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 4,136
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 (1)
- Lot number begins 508xxxx or lower
Distribution
Part of a larger recall action
This product is one of 14 recalled by Covidien LLC 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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