Medline red rubber urethral catheterization trays fail performance specifications
Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots because samples did not meet performance specifications. 235,658 units affected.
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: FDA Class II recall where a catheter connector can detach in use and dimensions fall out of specification, a risk of harm with no injuries reported.
Plain-English summary
The Medline Urethral Catheterization Tray and Bag with Red Rubber Latex catheter, 15 Fr, product number/SKU DYND18350, is being recalled. The action covers 235,658 units across all lots.
During an internal review, Medline identified that representative samples did not meet applicable performance specifications. According to the firm, the identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. The FDA classified the action as Class II.
Affected product is UDI/DI 10080196996759 for the each and 40080196996750 for the case. Distribution was worldwide, including nationwide in the United States.
Facilities should identify affected stock using the product number and UDI codes above, quarantine it, and follow the instructions issued by Medline.
The recalled product
- Product
- MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
- Manufacturer
- Medline Industries, LP
- Affected units
- 235,658
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 10080196996759 (each)
- 40080196996750 (case)
- ALL LOTS
Distribution
Part of a larger recall action
This product is one of 30 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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