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U.S. Department of Health and Human Services

Class 2 Device Recall Laparoscopy Pack

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 Class 2 Device Recall Laparoscopy Packsee related information
Date Initiated by FirmFebruary 06, 2025
Date PostedMarch 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1331-2025
Recall Event ID 96343
Product Classification laparoscopy kit - Product Code FDE
ProductLAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Code Information 1. Model No. CALS41F UDI-DI 00191072215727 Tray Lots 962241 70-050280 70-050870 70-051556 2. Model No. CALS41F-01 UDI-DI 00191072215727 Tray Lot 70-052412 3. Model No. CALS41G UDI-DI 00191072233332 Tray Lot 70-053051
Recalling Firm/
Manufacturer		 American Contract Systems Inc
85 Shaffer Park Dr
Tiffin OH 44883-9290
For Additional Information ContactMarlene Jones
419-455-2090
Manufacturer Reason
for Recall		ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
FDA Determined
Cause 2		Process control
ActionThe affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.
Quantity in Commerce303 kits
DistributionUS Nationwide distribution in the state of OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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