Merit Medical's Custom Procedural Trays or Kits containing 1%… — Class I medical device recall Z-0980-2014
Terminated recall by Merit Medical Systems, Inc., reported 2014-02-26, distributed nationwide. Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed cust
| Recall number | Z-0980-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., Chester, VA, United States |
| Recall initiated | 2013-09-30 |
| Classified | 2014-02-20 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2014-05-13 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| Lot numbers | 12T-06228, 12T-06462A, 25-090-DK, 475118, 481071, 483643, 483910, 484028, 489341, 489467, 510217, 71869, K05T-01920D, K09T-10692B, K09T-11022C, K10T-01343D, K10T-04110B, K10T-04147C, K10T-04192G, K10T-04338B, K10T-04359C, K10T-04655A, K10T-04675F, K10T-04675G, K10T-04888, K10T-05012A, K10T-05068, K10T-05090, K10T-05165A, K12-05663A, K12T-01652H, K12T-01751J, K12T-01852H, K12T-01938C, K12T-02007F, K12T-02018, K12T-02098, K12T-02169B, K12T-02185G, K12T-02363B and 376 more |
| Expiration dates | 2014-07-31, 2014-10-31, 2014-11-30, 2014-12-31 |
Product
Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Reason for recall
Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. The particular matter may dislodged through the tissue and could possibly cause a pneumothorax or hemothorax.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0980-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.