Recall record at a glance
| Official record | Z-1102-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Baxter Healthcare Corporation |
| Report date | Feb 17, 2021 |
| Recall initiation date | Dec 21, 2020 |
| Quantity | 66,800 units |
| Location | Deerfield, IL, United States |
Official product description
Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use.
Why the product was recalled
There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
Distribution information
Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.
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: E-Mail.
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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