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U.S. Department of Health and Human Services

Class 2 Device Recall PAJUNK

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 Class 2 Device Recall PAJUNKsee related information
Date Initiated by FirmOctober 10, 2022
Date PostedNovember 23, 2022
Recall Status1 Terminated 3 on January 17, 2024
Recall NumberZ-0278-2023
Recall Event ID 91037
Product Classification Epidural anesthesia kit - Product Code OGE
ProductPAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000.
Code Information Lot 0001359, Exp. date 2024-04-01, UDI (01) 00858965006007(17)240401(10)0001859..
Recalling Firm/
Manufacturer		 Pajunk Medical Systems, L.P.
4575 Marconi Drive
Alpharetta GA 30005
For Additional Information ContactAngela Meyer
770-493-6832
Manufacturer Reason
for Recall		The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.
FDA Determined
Cause 2		Process control
ActionThe recalling firm issued recall letters dated 10/10/2022 via email and overnight mail on 10/10/2022. The letter identified the product, the reason for recall and requested return of the affected lot as soon as possible. A return label was enclosed for return of product. A Customer Acknowledgment form was enclosed for return via email to report the quantity of product being returned. The form also asked the consignee if they remembered any used trays containing the 2ml ampule 0.75% Spinal Marcaine instead of the tray containing a 10ml ampule 0.9% Sodium Chloride. If the answer was yes, the consignee was to report whether the Marcaine was used and were there any adverse outcomes.
Quantity in Commerce280 trays
DistributionUS Nationwide distribution in the states of CA, NC, TN, PA, and TX.
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.
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