Lifeguard Infusion Set with Smartsite — Class II medical device recall Z-0914-2013
Terminated recall by Churchill Medical Systems, Inc., reported 2013-03-13, distributed nationwide. The label on the device states that the item number is CLGY-2210 when the item number on the device label shou
| Recall number | Z-0914-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Churchill Medical Systems, Inc., Dover, NH, United States |
| Recall initiated | 2013-01-21 |
| Classified | 2013-03-06 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2013-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 2,340 |
| Reason classes | labeling |
| Lot numbers | 1210099 |
Product
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Reason for recall
The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
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-0914-2013. 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.