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.
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
UDI/DI 10197344148998 (each), 20197344148995 (case); ALL LOTS
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.