MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against cath
Hazard
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.
What You Should Do
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 recalls@teleflex.com. Customers with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 610-378-0131.
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Products
- Brand
- Arrow International Inc
- UPC
- 510K # K002507; Material number: ASK-21142-HF2
Units Affected
unknown-firm reports total devices distributed 43,394 eaches