FDA (Devices) recall action 98994
The FDA (Devices) publishes a recall like this one as 30 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 30 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline Bilateral Micro Vasectomy Reversal kits are being recalled because representative samples did not meet applicable catheter performance specifications. 588 units affected.
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.
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.
Medline Pre-connected Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots. The action covers 4,304,669 units.
Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 14 Fr, are being recalled across all lots because samples did not meet performance specifications. 8,260 units affected.
Medline CV Draping/Basin procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,432 units are affected.
Medline gynaecology procedure kits including basic GYN, D&C hysteroscopy and GYN laparoscopy packs are being recalled over catheter specification failures. 44,656 units affected.
Medline CV and peripheral vascular procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,248 units affected.
Medline CRANI procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 3,521 units are affected.
Medline procedure kits including adult tracheostomy tube insertion, T&A and ear packs are being recalled because sample catheters did not meet performance specifications. 217,390 units affected.
Medline Oral Restoration procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications.
Medline procedure kits labeled Dr Fernandez are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.
Medline medical procedure kits including ECMO chest exploration, coronary artery bypass and D&C/cysto trays are being recalled because sample catheters did not meet performance specifications.
Medline Pelvic Lap Packs are being recalled because representative samples did not meet applicable catheter performance specifications. 20 units are affected.
Medline gynaecology procedure packs including hysteroscopy, D&C and tubal ligation kits are being recalled because sample catheters did not meet performance specifications. 37,324 units affected.
Medline procedure kits including the Bioburden Test Kit and Kit Uro Robot Cystectomy are being recalled because sample catheters did not meet performance specifications. 123,030 units affected.
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.
Medline Carotid Neuro Packs and VP Shunt CDS kits are being recalled because representative samples did not meet applicable catheter performance specifications. 342 units affected.
Medline D and C Packs and a custom cardiovascular pack are being recalled because representative samples did not meet applicable catheter performance specifications. 168 units affected.
Medline cardiac procedure kits including basic heart, cardiac surgery, carotid endarterectomy and ECMO packs are being recalled over catheter specification failures. 4,801 units affected.
Medline urology urethroplasty procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.
Medline Tonsil Pack Cath procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 384 units are affected.
Medline Nursing Kits, SKU EDUC1044, are being recalled because representative samples did not meet applicable catheter performance specifications. 730 units are affected.
Medline Laparoscopy Combined - No Ndl procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 72 units affected.
Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 16 Fr, are being recalled across all lots because samples did not meet performance specifications. 10,980 units affected.