Summary
The FDA issued a Class II for Various hysterectomy, vaginal packs by American Contract Systems, Inc.. Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures..
Details
Source
Device Recall
External ID
Z-1702-2022
Action Date
2022-09-14
Status
Ongoing
Category
device
Product Description
Various hysterectomy, vaginal packs
Lot/Code Info: Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRGYOSCOPYG, 2104281, 888211, 63995389 2) LSRLMGLAPF, 2105282, 856211, 44252282 3) LSRHPGYND, 2106092, 847211, 14887375 4) LSRHPGYND, 2106092, 847211, 14887374 5) LSRHPGYND, 2106092, 847211, 14887373 6) AMJL22Z, 2106112, 840211, 64176443 7) FDMN88N, 2107013, 821211, 64168939 8) MMJL16C, 2108023, 791211, 44180974 9) UIGY37AA, 2108033, 789211, 64104498 10) FHGG12V, 2109131, 748211, 64223133 11) BHOB33G, 2104191, 894211, 14870011-004 12) AHHY33M, 2105131, 867211, 14874336-004 13) MEHY02M, 2106152, 834211, 15003746-004 14) MEHY02M, 2106152, 834211, 15003740-004 15) MEHY02M, 2106152, 834211, 15003713-004 16) MEHY02M, 2106152, 834211, 15003709-004 17) MEHY02M, 2106152, 834211, 15003704-004 18) MEHY02M, 2106152, 834211, 15001377-004 19) MEHY02M, 2106152, 834211, 15003712-004 20) CXVG89X, 2106171, 833211, 43996010-005 21) SLGG63G, 2106282, 821211, 64071565-006 22) BHVR88A, 2106291, 828211, 64090094-006 23) UMVG16A, 2109031, 756211, 63998597-006 24) BHVP17H, 2106071, 845211, 14901608-004 25) BHVP17H, 2106071, 845211, 14901609-004 26) BHVP17H, 2108051, 785211, 15028595-004 27) BHVP17H, 2109031, 755211, 15023691-004 28) MCGY26E, 2109071, 754211, 44261563-005 29) MPGY64E, 2109081, 754211, 44261561-005
Quantity Affected: 29 units
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-16
Company
Kansas City, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems, Inc. have FDA actions?
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1702-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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