AVID TruCustom PACEMAKER PACK — Class II medical device recall Z-0797-2018
Terminated recall by Avid Medical, Inc., reported 2018-03-07, distributed in IL, KY, LA, MA, MO, NY, OH, TX…. Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may conta
| Recall number | Z-0797-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avid Medical, Inc., Toano, VA, United States |
| Recall initiated | 2017-06-22 |
| Classified | 2018-02-28 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2018-10-12 |
| Distributed | IL, KY, LA, MA, MO, NY, OH, TX, VA, WI |
| Quantity | 8 |
| Reason classes | foreign material, sterility |
| Lot numbers | 1211878 |
| Model numbers | VAMK016 |
Product
AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016
Reason for recall
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
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-0797-2018. 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.