Recall record at a glance
| Official record | Z-0496-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Cure Medical LLC |
| Report date | Dec 10, 2014 |
| Recall initiation date | Nov 11, 2014 |
| Quantity | 192 cases = 1,920 boxes = 57,600 each |
| Location | Newport Beach, CA, United States |
Official product description
Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. Intended to be used by pediatric males and females for the purpose of bladder drainage
Why the product was recalled
Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the French Size 10 catheter lead to urethral trauma.
Distribution information
Nationwide Distribution
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
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