Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow

FDA device recall Z-1057-2013 · posted 2013-04-04 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of updating the labeling for these products. In the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast

Action taken

Arrow sent an Urgent Medical Device Customer Notification letter dated March 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Arrow is in the process of updating the labeling; in the meantime they wanted to instruct all customers to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow settings specified in the current IFU. In addition, they are placing an insert card in kits for the specified product codes alerting them that Renografin-76 is no longer available and to select a contract medium with a viscosity of 8/4 centipose or lower for use with the pressure and flow setting specified in the current IFU. Arrow remains committed to providing high quality, safe and effective products. If you require additional information or clarification regarding this matter, please contact your Sales Representative or Arrow's Customer Service Department at (866) 396-2111.

Root cause

Labeling Change Control

Status

Terminated

Product code

DYG

Quantity affected

99627ea

Distribution

Worldwide Distribution - USA including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV,

Date initiated

2013-03-04

Date posted

2013-04-04

Date terminated

2013-12-21

Location

Reading, PA

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