Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
- Company
- Deroyal Industries Inc
- Recall Initiated
- May 30, 2023
- Posted
- July 3, 2023
- Recall Number
- Z-2090-2023
- Quantity
- 306 packs
- Firm Location
- Powell, TN
Reason for Recall
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Distribution
US Nationwide distribution.
Lot / Code Info
a) REF 89-7102, GTIN 50749756734085 (cs), 00749756734080 (unit), Lot Numbers: 58806701; b) REF 89-7322, GTIN 50749756736171 (cs), 00749756736176 (unit), Lot Numbers: 58821231; c) REF 89-9183, GTIN '0749756904846 (cs), 00749756904841 (unit), Lot Numbers: 58741944
Root Cause
Process control
Action Taken
DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.
More recalls by Deroyal Industries Inc
DeRoyal REF 71-C5100NS Tubing, Suction, Connector;
DeRoyal REF 71-C6100NS Tubing, Suction, Connector...
Mar 5, 2025
DeRoyal AMG Suction Connector Tubing REF:
71-2083,
71-C506,
71-C510,
71-C512,
71-C520,
Tubing is in...
Feb 14, 2025
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Nov 5, 2024