Medline 15 Fr urethral catheterization trays fail performance specifications
Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled because samples did not meet performance specifications. 8,327,756 units are affected.
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: 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
Medline Urethral Catheterization Trays, red rubber latex, 15 Fr, product numbers DYNC1816 and DYND10350, are being recalled. The action covers 8,327,756 units.
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 10080196990627 for the each and 40080196990628 for the case for DYNC1816, with the DYND10350 codes listed in the recall notice. Distribution was worldwide, including nationwide in the United States and to the United Arab Emirates, Barbados, Bermuda, the Bahamas, Canada, Cyprus, Guam, the Netherlands, Panama, Qatar, Saudi Arabia and the US Virgin Islands.
Facilities should identify affected stock using the product numbers and UDI codes in the recall notice, quarantine it, and follow the instructions issued by Medline.
The recalled product
- Product
- MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
- Manufacturer
- Medline Industries, LP
- Affected units
- 8,327,756
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 (6)
- 1. DYNC1816
- UDI/DI 10080196990627 (each)
- 40080196990628 (case)
- 2. DYND10350
- UDI/DI 10080196028665 (each)
- 40080196028666 (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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