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Class 1 Device Recall Clean Catch Urine Kit |
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Date Initiated by Firm |
May 02, 2022 |
Date Posted |
July 01, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1276-2022 |
Recall Event ID |
90324 |
Product Classification |
Culture media, non-propagating transport - Product Code JSM
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Product |
Clean Catch Urine Kit NS 178489, AHMU58A |
Code Information |
UDI-DI: 00191072120557
Lots 891211, 737211, 699211, 986221 |
Recalling Firm/ Manufacturer |
American Contract Systems, Inc. 2610 Ne Industrial Dr Ste 220 Kansas City MO 64117-2648
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For Additional Information Contact |
Angela L. Bunn 479-364-7174
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Manufacturer Reason for Recall |
Affected products were assembled off-site by individuals who may not have been properly trained.
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FDA Determined Cause 2 |
Process control |
Action |
On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits. |
Quantity in Commerce |
274,400 kits total |
Distribution |
US distribution in the state of Minnesota. |
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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