Gish 3/8 x 1/2" Reducer Connector with Luer fitting — Class II medical device recall Z-0158-2013
Terminated recall by Sorin Group USA, Inc., reported 2012-10-31, distributed nationwide. Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at t
| Recall number | Z-0158-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2012-09-14 |
| Classified | 2012-10-25 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,380 units |
| Reason classes | packaging |
| Lot numbers | 1108900099, 1119900091, 1203700129, 1208600013, 1219200107 |
| Model numbers | EC2180S |
| Expiration dates | 2014-03-31 |
Product
Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in extracorporeal blood or fluid circuits. The connectors are distributed as sterile stand alones and bulk non-sterile.
Reason for recall
Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury.
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-0158-2013. 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.