Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
Recall
- Recall Number
- Z-2774-2016
- Event Number
- 74898
- Firm
- Arrow International Inc
- FEI Number
- 3015859709
- Product Code
- LJS
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- February 17, 2016
- Terminated
- October 18, 2017
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607
Description
Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
The firm, Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 02/19/2016 via FedEx 2-day delivery to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of the affected products found; return product-a customer service representative will contact you with a RGA number and instructions; and complete and return the enclosed Recall Acknowledgement Form via fax to 1-855-419-8507 Attn: Customer Service or email to [email protected], even if you do not have no affected product. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
US Distribution to states of: NC, OH, FL, and MD.
6,121 units in total