Recall Z-0278-2023 ยท OGE Epidural Anesthesia Kit
Pajunk Medical Systems, L.P.
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.
| Date | Nov 23, 2022 (initiated Oct 10, 2022) |
| Status | Terminated |
| Reason | The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,. |
| Root cause | Process control |
| 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, th |
| Quantity | 280 trays |
| Distribution | US Nationwide distribution in the states of CA, NC, TN, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.