Z-2307-2017Class II
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r)...
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-03-20 / Terminated
Arrow International Inc began a recall of ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days)... on . FDA classified it as Class II and gives the reason as "The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2307-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- Product
- ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
- Product code
- FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Reason for recall
- The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard Blue antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. Clinical data have not been collected that demonstrate the use of the ARROWg+ard Blue antimicrobial surface in decreasing catheterrelated infections in hemodialysis patients. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
- FDA root cause
- Under Investigation by firm
- Action
- Arrow International sent an Urgent Medical Device Notification Letter dated April 5, 2017, to affected customers to inform them of the issue. The notice provided safety instructions for using the product and instructed customers to return the enclosed acknowledgement form indicating the notice was received, and fax it to 855-419-8507, Attn: Customer Service or email to [email protected]. Customers with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 610-378-0131.
- Quantity in commerce
- unknown-firm reports total devices distributed 43,394
- Distribution
- Nationwide Distribution
- Product codes and lots
- Material number CDA-22122-U1A
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2253-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2254-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2255-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2256-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2257-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2258-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2259-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2260-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2261-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2262-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2263-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2264-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2265-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2266-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2267-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2268-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2269-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2270-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2271-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2272-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2273-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2274-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2275-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2276-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2277-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2278-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2279-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2280-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2281-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2282-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2283-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2284-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2285-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2286-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2287-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2288-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2289-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2290-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2291-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2292-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2293-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2294-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2295-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2296-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2297-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2298-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2299-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2300-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2301-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2302-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2303-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2304-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2305-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2306-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2307-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2308-2017 | Class II | Terminated | Voluntary: Firm initiated |
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