ClearanceBrief
Recall Z-1835-2024 ยท KGX Tape And Bandage, Adhesive

Cardinal Health 200, LLC

CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.

DateMay 16, 2024 (initiated Apr 17, 2024)
StatusOpen, Classified
ReasonPotential contamination of the product with latex adhesive residual.
Root causeUnder Investigation by firm
ActionOn 4/17/2024, the recalling firm issued letters dated 4/17/2024 via overnight mail explaining the reason for recall, the risk to health, and the required actions, which were: (1) Review inventory for the affected product code and lot number; (2) communicate with all personnel that utilize the product; (3) segregate and quarantine all affected product and utilize the return directions in the letter; (4) disseminate the notice to all departments, clinics, and external campuses that handle the affected product; (5) distributors are to notify any customers to whom they may have distributed/forwar
Quantity2,000 packages
DistributionUS Nationwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.