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U.S. Department of Health and Human Services

Class 2 Device Recall Design Options / Epidural anesthesia kit

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 Class 2 Device Recall Design Options / Epidural anesthesia kitsee related information
Date Initiated by FirmJune 05, 2023
Date PostedJune 23, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2003-2023
Recall Event ID 92523
Product Classification Epidural anesthesia kit - Product Code OGE
ProductDesign Options / Epidural anesthesia kit (10 count carton)
Code Information Model No. 552177, 552155, 552179, 552116; GTIN: 04046955596102, 04046955214440, 04046955596140, 04046964950254; Lot No. 0061853751, 0061854949, 0061855598, 0061855133.
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information ContactPostmarket Surveillance Department
833-425-1464
Manufacturer Reason
for Recall		Kits were assembled with the incorrect Filter Straw.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionCustomers received a recall notification dated 06/05/2023 by mail notifying them that affected lots of Epidural Kits were inadvertently assembled with the incorrect Filter Straw. The recall notification asks customers to determine if any affected devices are in inventory and subsequently quarantine any identified product, return the Product Recall Acknowledgement Form notating any affected devices currently in quarantine, and return the form by fax to 610-849-1197 or by email to PA_QualityAssurance.BBMUS_Service@bbraunusa.com. Coordination of product return for provision of credit/replacement will commence upon return of the form. If product has been further distributed the firm asks that the recall notification be forwarded to those consignees down to the consumer level. Customers with any questions can direct them to BBMI's Postmarket Surveillance Department at 1-883-425-1464.
Quantity in Commerce3,560 units
DistributionUS Nationwide distribution.
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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