Sterile tape/pen pack recalled for potential sterility breach
Medline M1S0179 sterile tape/pen packs may have weak seals that could compromise product sterility. The weakness may not be visible during normal inspection.
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: This is a Class II recall involving a medical device with potential for sterility breach, which presents a risk of harm. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Medline Industries has recalled the M1S0179 Sterile Tape/Pen Pack. The affected product may have weak seals on the packaging that could result in sterility breach.
A weak seal may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users during visual inspection or normal handling.
The recalled products were distributed worldwide, including the United States, Panama, and Canada. The affected batch is identified by lot numbers 2023031590 and 2023070390 and product code P519582A.
If you have received this product, contact Medline Industries for guidance on verifying seal integrity or obtaining replacement units.
The recalled product
- Product
- MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Affected units
- 4,200
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 (3)
- UDI/DI 20193489111375 (case) 10193489111378 (each)
- Lot Numbers: 2023031590
- 2023070390
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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