Device product
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
Z-2090-2023
Product summary
- Event
- Event 92445
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 306 packs
- Official record key
device-enforcement:Z-2090-2023
Official wording
Reason: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Code information: 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
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
package seal could be open, or compromised
-
Sterility assurance
package seal could be open, or compromised which affects the sterility