Moderate riskFDA DeviceClass II

Medline Convenience Nail Kit (POD14214) recalled for sterility concerns

Medline is recalling specific lots of its Convenience Nail Kit because the sterile saline wound wash component may not meet required sterility standards. The affected product was distributed nationwide and to several Caribbean locations. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Check if you have a Medline Convenience Nail Kit, Model POD14214
  2. Look up your lot number against the list: 25CBS147, 25CBJ329, 25ABU209, 24DBJ364, 24DBB718, 23JBV524, 23IBU998, or 23IBF119
  3. Stop using the kit if you have one of these lots
  4. Contact Medline or your supplier for instructions on return or replacement

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 5 products — see all of them.

Details

Units affected
1640 units
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-1432-2026

In the FDA's words

Description
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214 Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. 1) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25CBS147; 2) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25CBJ329; 3) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25ABU209; 4) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 24DBJ364; 5) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 24DBB718; 6) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23JBV524; 7) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23IBU998; 8) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23IBF119 Distribution: Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands. Affected quantity: 1640 units
Hazard
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

5 products in this recall

Medline and Meijer saline wound wash recalled for sterility concerns

Medline reported that the manufacturer of its sterile saline wound wash may not have made the products to the required sterility assurance level. The recall covers five products: a saline wound wash sold under the Medline and Meijer names, plus several Medline convenience kits. No injuries have been reported, and the products were distributed across the US and to the Bahamas, Bermuda, and the Cayman Islands.

The agency lists each product separately. Check every one you might have.

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Related topics

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