Churchill Medical Systems — Class II medical device recall Z-0937-2013
Terminated recall by Vygon Corporation, reported 2013-03-20, distributed in PA. Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is includ
| Recall number | Z-0937-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vygon Corporation, Lansdale, PA, United States |
| Recall initiated | 2012-12-17 |
| Classified | 2013-03-11 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2014-01-14 |
| Distributed | PA |
| Quantity | 210 |
| Reason classes | labeling |
| Lot numbers | MBKQ640, MBKZ720, MBLJ290, MBLR100, MBLZ350, MBMG250 |
| Expiration dates | 2015-05, 2015-06, 2015-07, 2015-09, 2015-10 |
Product
Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
Reason for recall
Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
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-0937-2013. 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.