| | Class 2 Device Recall Custom procedural convenience kits and trays |  |
| Date Initiated by Firm | November 29, 2023 |
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| Date Posted | January 26, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0827-2024 |
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| Recall Event ID |
93656 |
| Product Classification |
Neurological tray - Product Code OJG
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| Product | Custom procedural convenience kits and trays, general hospital use, labeled as:
a) IR NEURO PACK, kit number AGNE20J;
b) ADULT CRANIOTOMY PACK, kit number LLCR99;
c) LAMINECTOMY PACK, kit number LLLC26;
d) KIT, CRANIOTOMY, kit number MMCR11J;
e) KIT, NEURO SPINE, kit number MMNS20H;
f) IR NEURO PACK, kit number OSIN77;
g) NEURO SAH, kit number SANE32H;
h) NEURO SAH, kit number SANE32I;
i) S78FCH CRANI PACK (PS 132432), kit number UICR10U;
j) CRANI PACK (PS039498), kit number UICR33AW;
k) Laminectomy, kit number UILM77AR;
l) DIAGNOSTIC NEURO IR TRAY, kit number WENE21D;
m) DIAGNOSTIC NEURO IR TRAY, kit number WENE21F;
n) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H;
o) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H-01;
p) NEURO IR TRAY, kit number WENI56F;
q) NEURO IR TRAY, kit number WENI56H;
r) NEURO IR TRAY, kit number WENI56H-01 |
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| Code Information |
a) AGNE20J, UDI/DI 00191072183187, Lot Numbers: 934231, exp. 10/30/2023; 900231, exp. 4/10/2024; 990231, exp. 1/10/2024; 687221, exp. 11/9/2023; 720221, exp. 10/7/2023; 757221, exp. 8/31/2023; 870221, exp. 5/10/2023; 702221, exp. 10/25/2023; 795221, exp. 7/24/2023;
b) LLCR99, UDI/DI 00191072162755, Lot Numbers: 756221, exp. 9/1/2023; 720221, exp. 10/7/2023; 654221, exp. 12/12/2023; 949231, exp. 2/20/2024;
c) LLLC26, UDI/DI 00191072171900, Lot Numbers: 749221, exp. 9/8/2023; 695221, exp. 11/1/2023; 997231, exp. 1/3/2024; 920231, exp. 3/21/2024;
d) MMCR11J, UDI/DI none, Lot Numbers: 744221, exp. 9/13/2023; 939231, exp. 3/2/2024; 876231, exp. 5/4/2024;
e) MMNS20H, UDI/DI none, Lot Numbers: 963231, exp. 2/6/2024; 959231, exp. 2/10/2024;
f) OSIN77, UDI/DI 00191072170705, Lot Numbers: 780221, exp. 8/8/2023; 728221, exp. 9/29/2023; 668221, exp. 11/28/2023; 991231, exp. 1/9/2024, 960231, exp. 2/9/2024; 939231, exp. 3/2/2024; UDI/DI 00191072190031, Lot Numbers: 912231, exp. 3/29/2024; 903231, exp. 4/7/2024;
g) SANE32H, UDI/DI none, Lot Numbers: 838221, exp. 6/11/2023; 889221, exp. 4/21/2023;
h) SANE32I, UDI/DI none, Lot Numbers: 673221, exp. 11/23/2023; 730221, exp. 9/27/2023; 784221, exp. 8/4/2023; 911231, exp. 3/30/2024; 969231, exp. 1/31/2024;
i) UICR10U, UDI/DI none, Lot Numbers: 990231, exp. 1/10/2024; 921231, exp. 3/20/2024; 885231, exp. 4/25/2024;
j) UICR33AW, UDI/DI none, Lot Numbers: 658221, exp. 12/8/2023; 931231, exp. 3/10/2024; 876231, exp. 5/4/2024;
k) UILM77AR, UDI/DI 00191072139184, Lot Numbers: 953231, exp. 2/16/2024; 905231, exp. 4/5/2024;
l) WENE21D, UDI/DI 00191072167958, Lot Numbers: 839221, exp. 6/10/2023;
m) WENE21F, UDI/DI 00191072167958, Lot Numbers: 819221, exp. 6/30/2023;
n) WENE21H, UDI/DI 00191072179326, Lot Numbers: 729221, exp. 9/28/2023; 686221, exp. 11/10/2023;
o) WENE21H-01, UDI/DI 00191072179326, Lot Numbers: 980231, exp. 1/20/2024;
p) WENI56F, UDI/DI 00191072169341, Lot Numbers: 799221, exp. 7/20/2023;
q) WENI56H, UDI/DI 00191072179333, Lot Numbers: 700221, exp. 10/27/2023;
r) WENI56H-01, UDI/DI 00191072179333, Lot Numbers: 652221, exp. 12/14/2023; 996231, exp. 1/4/2024 |
Recalling Firm/
Manufacturer |
American Contract Systems, Inc.
7802 E Telecom Pkwy
Temple Terrace FL 33637-0928
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| For Additional Information Contact | Marlene Jones
470-280-4277 |
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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. |
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FDA Determined
Cause 2 | Process control |
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| 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.
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| Quantity in Commerce | 2717 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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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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