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U.S. Department of Health and Human Services

Class 2 Device Recall Custom procedural convenience kits and trays

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  Class 2 Device Recall Custom procedural convenience kits and trays see related information
Date Initiated by Firm November 29, 2023
Date Posted January 26, 2024
Recall Status1 Open3, Classified
Recall Number Z-0817-2024
Recall Event ID 93656
Product Classification Cardiac catheterization kit - Product Code OES
Product Custom procedural convenience kits and trays, cardiac, labeled as:
a) HEART CATHETERIZATION TRAY, kit number JRHC45G;
b) TAVR PACK, kit number LLTV10;
c) CATH PED LF SJH, kit number SJCA21F;
d) CATH HEART ADL LF SJH, kit number SJCH22F;
e) INT RAD PORTS-LF - 206060, kit number UDIR58AL
Code Information a) JRHC45G, UDI/DI 00191072164240, Lot Numbers: 912231, exp. 3/29/2024; 920231, exp. 3/21/2024; 952231, exp. 2/17/2024; 963231, exp. 2/6/2024; 976231, exp. 6/2/2023; 654221, exp. 12/12/2023; 714221, exp. 10/13/2023; 717221, exp. 6/7/2023; 766221, exp. 8/22/2023; 814221, exp. 7/5/2023; b) LLTV10, UDI/DI 00191072183255, Lot Numbers: 644221, exp. 12/22/2023; 973231, exp. 1/27/2024; 952231, exp. 2/17/2024; 924231, exp. 3/17/2024; c) SJCA21F, UDI/DI None, Lot Numbers: 666221, exp. 11/30/2023; 701221, exp. 10/26/2023; 747221, exp. 9/10/2023; 779221, exp. 8/9/2023; 807221, exp. 7/12/2023; 846221, exp. 6/3/2023; 919231, exp. 3/22/2024; 954231, exp. 2/15/2024; 988231, exp. 1/12/2024; d) SJCH22F, UDI/DI None, Lot Numbers: 670221, exp. 11/26/2023; 708221, exp. 10/19/2023; 747221, exp. 9/10/2023; 795221, exp. 7/24/2023; 834221, exp. 6/15/2023; 873221, exp. 5/7/2023; 937231, exp. 3/4/2024; 991231, exp. 1/9/2024; e) UDIR58AL, UDI/DI None, Lot Numbers: 682221, exp. 11/14/2023; 638221, exp. 7/31/2023; 963231, exp. 2/6/2024; 925231, exp. 3/16/2024; 883231, exp. 10/30/2023
Recalling Firm/
Manufacturer		 American Contract Systems, Inc.
7802 E Telecom Pkwy
Temple Terrace FL 33637-0928
For Additional Information Contact Marlene Jones
470-280-4277
Manufacturer Reason
for Recall		 During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
FDA Determined
Cause 2		 Process control
Action Owens & Minor issued an URGENT: MEDICAL DEVICE CORRECTION notice to it consignees on 11/29/2023 via email. Then notice explained the problem, risk to health, and requested the following actions be taken: If you received any of the batches/lots identified, please segregate and quarantine all affected product. Add warning labels to all kits/cases impacted: A labeling template is enclosed for printing warning labels which should be affixed to all affected product in inventory. This label should be affixed to each affected kit and case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. " Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this field correction and maintain records of effectiveness. Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.
Quantity in Commerce 4394 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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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