Z-2272-2017Class II
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue...
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-03-20 / Terminated / root cause: packaging
Arrow International Inc began a recall of Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The... on . FDA classified it as Class II and gives the reason as "Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-2272-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- Product
- Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: 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
- Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
- Root cause tag
- packaging
- 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.
- Distribution
- Nationwide Distribution
- Product codes and lots
- Material number ASK-42703-PRJ
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 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.