Drug recall
Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated…
FDA recall event 67588 · Class II · Convatec Inc.
Key facts
| Event ID | 67588 |
|---|---|
| Recall numbers | Z-1236-2014, Z-1237-2014, Z-1238-2014, Z-1239-2014, Z-1240-2014, Z-1241-2014 |
| Recalling firm | Convatec Inc. |
| Product type | Devices |
| Products | Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated…, JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major…, Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous…, SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube…, SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which… and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. |
| Initiation date | Feb 7, 2014 |
| Report date | Mar 26, 2014 |
| Termination date | Dec 18, 2014 |
| City | Skillman |
| State | NJ |
| Country | United States |
| FEI number | 2243969 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: