Medline nail kits recalled over saline wound wash sterility failure
Medline is recalling Nail Kit convenience kits, model POD14214, because the manufacturer of the sterile saline wound wash they contain may not have met the required sterility assurance level.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a kit containing a wound-care product whose sterility cannot be assured, with no injuries stated in the source.
Plain-English summary
Medline Industries, LP is recalling Medline convenience Nail Kits, model number POD14214. About 1,640 units were distributed worldwide, covering the United States nationwide and the Bahamas, Bermuda and the Cayman Islands. The FDA has classified this recall as Class II.
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.
Affected product carries UDI-DI 10889942819362 (each) and 40889942819363 (case), across lot numbers 25CBS147, 25CBJ329, 25ABU209, 24DBJ364, 24DBB718, 23JBV524, 23IBU998 and 23IBF119.
Facilities can identify affected kits by the model number, UDI and lot codes above, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Convenience kit
- Affected units
- 1,640
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 (18)
- 1) POD14214
- UDI-DI: 10889942819362(each)
- 40889942819363(case)
- Lot Number: 25CBS147
- 2) POD14214
- Lot Number: 25CBJ329
- 3) POD14214
- Lot Number: 25ABU209
- 4) POD14214
- Lot Number: 24DBJ364
- 5) POD14214
- Lot Number: 24DBB718
- 6) POD14214
- Lot Number: 23JBV524
- 7) POD14214
- Lot Number: 23IBU998
- 8) POD14214
- Lot Number: 23IBF119
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Medline Industries, LP 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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