Tearaway Introducer — Class II medical device recall Z-1924-2016
Terminated recall by Medical Components, Inc dba MedComp, reported 2016-06-15, distributed in FL, NC, TX. This recall has been initiated due to the product labeled with the incorrect expiration date.
| Recall number | Z-1924-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Components, Inc dba MedComp, Harleysville, PA, United States |
| Recall initiated | 2016-05-05 |
| Classified | 2016-06-07 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2017-06-16 |
| Distributed | FL, NC, TX |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884908105209, 00884908105216 |
| Lot numbers | MBZ140, MBZL450, MBZV930, MBZX140, MBZZ490 |
| Model numbers | 130687, 510K, VS203, VS303 |
| Expiration dates | 2020-11-14, 2021-01-18, 2021-01-28, 2021-11-01 |
Product
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
Reason for recall
This recall has been initiated due to the product labeled with the incorrect expiration date.
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-1924-2016. 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.