Recall record at a glance
| Official record | Z-0723-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Arrow International Inc. |
| Report date | Jan 23, 2019 |
| Recall initiation date | Nov 14, 2018 |
| Quantity | 15 in the US |
| Location | Reading, PA, United States |
Official product description
Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products
Why the product was recalled
The lidstock states the incorrect priming volume and flow rates.
Distribution information
Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, and Peru.
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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