PAJUNK 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.
FDA Recall Z-0278-2023 · Posted 2022-11-23
Advertisement
Recalling FirmPajunk Medical Systems, L.P.
Recall StatusTerminated
Product CodeOGE
Date Initiated2022-10-10
Date Terminated2024-01-17
Product Quantity280 trays
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,.
Firm Action
The 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of CA, NC, TN, PA, and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement