Recall record at a glance
| Official record | Z-2595-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Catheter Connections, Inc. |
| Report date | Sep 17, 2014 |
| Recall initiation date | Aug 5, 2014 |
| Quantity | 24,910 units |
| Location | Salt Lake City, UT, United States |
Official product description
DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
Why the product was recalled
Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.
Distribution information
US Distribution to states of: CT, GA, MD, and PA. .
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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