Recall record at a glance
| Official record | Z-0914-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Churchill Medical Systems, Inc. |
| Report date | Mar 13, 2013 |
| Recall initiation date | Jan 21, 2013 |
| Quantity | 2340 |
| Location | Dover, NH, United States |
Official product description
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Why the product was recalled
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.
Distribution information
Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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