Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Code information: LOTS: SL15183 (150619119) 30-JUN-16 SL15184 (150619119) 30-JUN-16 SL15187 (150619119) 30-JUN-16 SL15212 (150719823) 31-JUL-16 SL15215 (150719823) 31-JUL-16 SL15216 (150719823) 31-JUL-16 SL15217 (150720152) 31-JUL-16 SL15217 (150719823) 31-JUL-16 SL15219 (150719823) 31-JUL-16 SL15219 (150720152) 31-JUL-16 SL15223 (150720152) 31-JUL-16 SL15224 (150720152) 31-JUL-16 SL15225 (150719823) 31-JUL-16 SL15252 (150820683 31-AUG-16 SL15254 (150820683) 31-AUG-16 SL15257 (150820683) 31-AUG-16

Distribution pattern: Distributed only in Puerto Rico.