Device product
Various Laparoscopy Packs
Z-1694-2022
Product summary
- Event
- Event 90574
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 39 units
- Official record key
device-enforcement:Z-1694-2022
Official wording
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Code information: Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRENDOSCOPH, 2104281, 890211, 14887854 2) LSRENDOSCOPH, 2108251, 784211, 44375070 3) LSRENDOSCOPH, 2110011, 740211, 15140201 4) PLLA88I, 2104162, 895211, 14779054 5) AMGL09X, 2104281, 887211, 64029666 6) IHGB89AB, 2107293, 791211, 64104353 7) UIUA68AG, 2108202, 771211, 64233083 8) FRLC65S, 2104301, 882211, 44123696-005 9) MHLC19AH, 2105181, 863211, 63956744-006 10) CXRO12W, 2107082, 811211, 64110751-006 11) SLLP38F, 2107132, 807211, 64100877-006 12) SLLP38F, 2107132, 807211, 64100879-006 13) SLLP38F, 2107132, 807211, 64100878-006 14) CXLP87AJ, 2107162, 803211, 15011547-004 15) BHLC43J, 2108042, 784211, 44294507-005 16) BHLC43J, 2108042, 784211, 44234508-005 17) MERS50Q, 2108193, 769211, 64206337-006 18) BHRP78C, 2104131, 903211, 64073208-006 19) BHRP78C, 2104131, 903211, 64073209-006 20) BHRP78C, 2106221, 831211, 64091105-006 21) BHRP78C, 2106221, 831211, 64091104-006 22) BHRP78C, 2106233, 831211, 64090598-006 23) BHLP21C, 2107261, 800211, 44226340-005 24) BHLP21C, 2107261, 800211, 44226339-005 25) BHLP21C, 2107261, 800211, 44226341-005 26) BHLP21C, 2107261, 800211, 44226338-005 27) BHLP62E, 2107292, 799211, 44219340-005 28) BHLP62E, 2107292, 799211, 44219343-005 29) BHLP62E, 2107292, 799211, 44219342-005 30) BHLP62E, 2107292, 799211, 44219341-005 31) BHRP78C, 2108041, 789211, 64093909-006 32) BHRP78C, 2108041, 789211, 64092459-006 33) BHRP78C, 2108041, 789211, 64092460-006 34) BHLP62E, 2108242, 771211, 44336911-005 35) SARB30J, 2104291, 884211, 64040187-006 36) MCLC14F, 2106011, 853211, 44153023-005 37) MPRO72D, 2107131, 811211, 64129494-006 38) MCLC14F, 2109031, 760211, 44261569-005 39) AGLC19L, 2108191, 775211, 64186775-006
Distribution pattern: Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Derived failure modes
-
Unknown
Product was exposed to multiple sterilization cycles without validation for multiple exposures.