Recall record at a glance
| Official record | Z-2458-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medline Industries Inc. |
| Report date | Sep 2, 2015 |
| Recall initiation date | Aug 3, 2015 |
| Quantity | 320 units for lot 14DB9277 & 320 units for lot 14PB2878 |
| Location | Mundelein, IL, United States |
Official product description
Central Line >34 Weeks Kit . Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.
Why the product was recalled
The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
Distribution information
US including 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: Telephone.
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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