Zimmer Biomet Recalls BlockAid Cut Resistant Surgical Glove Liners
Zimmer Biomet is recalling BlockAid Cut Resistant Surgical Glove Liners because the product lacks sterility assurance. The recall affects 1,863 units distributed in 29 states and three countries.
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 involves a lack of sterility assurance in a surgical product, which presents a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling BlockAid Cut Resistant Surgical Glove Liners, which are designed to be worn between two layers of surgical gloves to provide cut resistance. The recall is being conducted because the product lacks sterility assurance. The affected item numbers are 650126, 650127, 650128, 650129, 650130, and 650131.
A total of 1,863 units were distributed in 29 states: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WV, and Washington, DC. The products were also distributed to one Veteran's Administration hospital in Missouri and in the Netherlands, Peru, and Switzerland.
The FDA has classified this recall as Class II. Consumers and healthcare facilities should stop using the affected products and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128
- Manufacturer
- Zimmer Biomet, Inc.
- Category
- Medical Device — Surgical Gloves
- Hazard
- Affected units
- 1,863
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)
- Item Number Lot Number Expiration Date: 1. 650126 326624 9/30/2017
- 2. 650126 330363 11/30/2017
- 3. 650128 330363 12/1/2017
- 4. 650129 330363 12/1/2017
- 5. 650129 351411 6/28/2018
- 6. 650127 353495 7/28/2018
- 7. 650128 353498 7/28/2018
- 8. 650131 353504 7/28/2018
- 9. 650129 357204 7/28/2018
- 10. 650128 361436 8/28/2018
- 11. 650129 361467 8/28/2018
- 12. 650128 000011 11/28/2018
- 13. 650128 231984 12/22/2018
- 14. 650129 000011 2/28/2019
- 15. 650128 379203 2/28/2019
- 16. 650131 390179 6/28/2019
- 17. 650131 395315 8/28/2019
- 18. 650128 259231 9/30/2019
- 19. 650127 401155 10/28/2019
- 20. 650130 402602 10/28/2019
Distribution
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