Recall record at a glance
| Official record | Z-0278-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Pajunk Medical Systems, L.P. |
| Report date | Nov 30, 2022 |
| Recall initiation date | Oct 10, 2022 |
| Quantity | 280 trays |
| Location | Alpharetta, GA, United States |
Official product description
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.
Why the product was recalled
The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.
Distribution information
US Nationwide distribution in the states of CA, NC, TN, PA, and TX.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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