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; 9. DYND13522 - 22 Fr; 10. DYND1

Medline Industries, LP

The hazard

During an internal review, Medline identified representative samples did not meet applicable performance specifications. 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. FDA Class II recall.

The remedy

Follow FDA guidance

About this recall

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; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.

Affected identifiers

Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.

Model 1. DYND13508Model UDI/DI 10080196031139 (each)Model 20080196031136 (case)Model 2. DYND13510Model UDI/DI 10080196726462 (each)Model 40080196726463 (case)Model 3. DYND13512Model UDI/DI 10080196031177 (each)Model 40080196031178 (case)Model 4. DYND13514Model UDI/DI 10080196726219 (each)Model 40080196726210 (case)Model 5. DYND13515Model UDI/DI 10080196031214 (each)Model 40080196031215 (case)Model 6. DYND13516Model UDI/DI 10080196031221 (each)Model 40080196031222 (case)Model 7. DYND13518Model UDI/DI 10080196031245 (each)Model 40080196031246 (case)Model 8. DYND13520Model UDI/DI 10080196031252 (each)Model 40080196031253 (case)Model 9. DYND13522UPC 10080196031139UPC 20080196031136UPC 10080196726462UPC 40080196726463UPC 10080196031177UPC 40080196031178UPC 10080196726219UPC 40080196726210UPC 10080196031214UPC 40080196031215UPC 10080196031221UPC 40080196031222UPC 10080196031245UPC 40080196031246UPC 10080196031252UPC 40080196031253UPC 10080196061259UPC 40080196061250UPC 10080196031276UPC 30080196031270UPC 10888277720879UPC 20888277720876

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Sourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.