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U.S. Department of Health and Human Services

Class 2 Device Recall Pain Control Trays

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 Class 2 Device Recall Pain Control Trayssee related information
Date Initiated by FirmAugust 27, 2015
Create DateOctober 21, 2015
Recall Status1 Terminated 3 on June 29, 2016
Recall NumberZ-0150-2016
Recall Event ID 72237
510(K)NumberK962696 
Product Classification Anesthesia conduction kit - Product Code CAZ
ProductPerifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
Code Information Product Catalog Number: 332215 332262 530024 530132 551714 551879 555184 555259 Lot Number 0061417406 0061421878 0061416371 0061420212 0061413247 0061416388 0061416389 0061414413 
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information ContactCustomer Support
610-596-2870
Manufacturer Reason
for Recall		Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
FDA Determined
Cause 2		Under Investigation by firm
ActionBBMI provided written notification, dated August 27, 2015, to all customers in receipt of suspect product, along with acknowledgement forms detailing the suspect product that was distributed to each account. These customers include both BBMI direct end customers and BBMI direct distributors. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. All customers were provided with instructions for disposition of suspect product in their inventory. Distributors shall be reminded of their responsibility in executing the recall.
Quantity in Commerce433
DistributionNationally
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CAZ
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