Recall record at a glance
| Official record | Z-2163-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | CORPAK MedSystems, Inc. |
| Report date | May 31, 2017 |
| Recall initiation date | Feb 3, 2017 |
| Quantity | 8 cases (2 units per case) |
| Location | Buffalo Grove, IL, United States |
Official product description
CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
Why the product was recalled
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Distribution information
Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
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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