Z-1694-2022 Class II Ongoing
FDA device recall Z-1694-2022 was initiated by American Contract Systems, Inc. on Jun 16, 2022 and is designated Class II. Reason for recall: Product was exposed to multiple sterilization cycles without validation for multiple exposures. The recall status is ongoing. Affected quantity: 39 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 14, 2022
- Initiation Date
- Jun 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 units
Product Description
Various Laparoscopy Packs
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
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
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1694-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026