Various Laparoscopy Packs recall
Various Laparoscopy Packs
Why was Various Laparoscopy Packs recalled?
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Various Laparoscopy Packs
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 39 units
- Distribution
- 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
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)