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U.S. Department of Health and Human Services

Class 2 Device Recall American Contract Systems

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 Class 2 Device Recall American Contract Systemssee related information
Date Initiated by FirmSeptember 01, 2023
Date PostedOctober 26, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0182-2024
Recall Event ID 93086
Product Classification Endoscope introducer kit - Product Code NWU
ProductCath Cardiac Pack, REF IHCC03V
Code Information UDI/DI 00191072189431, Lot Numbers: 724221, 679221, 945231
Recalling Firm/
Manufacturer		 American Contract Systems, Inc.
7802 E Telecom Pkwy
Temple Terrace FL 33637-0928
For Additional Information ContactMarlene Jones
470-280-4277
Manufacturer Reason
for Recall		During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
FDA Determined
Cause 2		Process control
ActionOwens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 09/01/2023 by email. The notice explained the issue, risk, and requested the user discontinue the use of the I.V. Cath and Adhesive Dermabond and affix a warning label to each kit and case of affected product in inventory. The firm sent an updated letter on 09/22/2023 via email which corrected the product distribution date.
Quantity in Commerce1260 units
DistributionUS Nationwide distribution in the states of FL, IA.
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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