Medline red rubber urethral catheters fail applicable performance specifications
Medline Urethral Catheters in red rubber latex, spanning French sizes 08 to 22, are being recalled because samples did not meet performance specifications. 2,237,471 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
Medline Urethral Catheters, red rubber latex, are being recalled across French sizes 08 through 22, covering product numbers DYND13508, DYND13510, DYND13512, DYND13514, DYND13515, DYND13516, DYND13518, DYND13520, DYND13522 and DYND13614, among the SKUs listed in the recall notice. The action covers 2,237,471 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.
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 Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr…
- Manufacturer
- Medline Industries, LP
- Affected units
- 2,237,471
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 (20)
- 1. DYND13508
- UDI/DI 10080196031139 (each)
- 20080196031136 (case)
- 2. DYND13510
- UDI/DI 10080196726462 (each)
- 40080196726463 (case)
- 3. DYND13512
- UDI/DI 10080196031177 (each)
- 40080196031178 (case)
- 4. DYND13514
- UDI/DI 10080196726219 (each)
- 40080196726210 (case)
- 5. DYND13515
- UDI/DI 10080196031214 (each)
- 40080196031215 (case)
- 6. DYND13516
- UDI/DI 10080196031221 (each)
- 40080196031222 (case)
- 7. DYND13518
- UDI/DI 10080196031245 (each)
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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