Class 1 Device Recall Kit: Blood Culture

• Date Initiated by Firm: April 09, 2021
• Date Posted: May 12, 2021
• Recall Status: Terminated on October 03, 2023
• Recall Number: Z-1559-2021
• Recall Event ID: 87722
• Product Classification: Blood specimen collection kit (excludes HIV testing) - Product Code OFZ
• Product: Kit: Blood Culture MAI Kit Part Number: 80076
• Code Information: Kit Number: 80076; UDI (GTIN): 20809160021269; Lot Number: 0000280292 (Expiration Date: 07/31/2021), 0000280766 (Expiration Date: 07/31/2021), 0000281206 (Expiration Date: 07/31/2021), 0000279153 (Expiration Date: 05/31/2021), and 0000280969 (Expiration Date: 06/30/2021)
• Recalling Firm/ Manufacturer: Medical Action Industries, Inc. 306; 25 Heywood Rd; Arden NC 28704-9302
• Manufacturer Reason for Recall: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
• FDA Determined Cause: Package design/selection
• Action: A written notification letter titled, "URGENT: RECALL NOTIFICATION" was sent to all consignees on 04/09/2021 via email. The letter sent to the distributors instructs the consignees to immediately examine all inventory locations and discontinue use of Medical Action trays affected by this recall. The consignees are instructed to discard any inventory they may have on hand in accordance with the distributor's facility s standard procedures. If any of the affected products identified above were further distributed, the distributor is to ensure all end-users are appropriately notified of this product recall and maintain records of effectiveness. An example of an end-user letter that the distributor can use to notify their customers is attached. The distributor is asked to please report number of responses received and quantities destroyed to Quality@owens-minor.com. The consignee is asked to complete the Recall Response Form and return it as soon as possible even if they do not have product inventory. If the facility has identified recalled product in their inventory, they are asked to please complete the attached Destruction of Material Authorization form when the recalled product is destroyed and return to Quality@owens-minor.com to receive credit. The letter also mentions that any adverse events associated with the use of the affected kits should be reported to Quality@owens-minor.com. The letter that was sent to the end users instructs the consignee to immediately examine all inventory locations and discontinue use of Medical Action trays affected by this recall. The consignee is to discard any inventory they may have on hand in accordance with their facility' s standard procedures. The consignee is to complete the Recall Response Form and return it as soon as possible even if the consignee has no current product inventory. If the facility has identified recalled product in their inventory, they are asked to please complete the attached Destruction of Ma
• Quantity in Commerce: 129 cases (20 kits per case)
• Distribution: Distributed US nationwide to OH, OR, FL and CA.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.