BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacture

FDA device recall Z-2074-2012 · posted 2012-07-24 · Terminated

Recall details

Recalling firm

Bridgepoint Medical

Reason for recall

BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal. In no case was there any reported adverse clinical event related to the problem.

Action taken

The firm, BridgePoint Medical, sent an "Urgent Field Safety Notice" letter dated June 26, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory, quarantine the affected lots and complete and return the enclosed "Verification Form" via fax to 763-225-8718 ,attn: BridgePoint Medical, Inc., Upon receipt of form, BridgePoint will supply the customers with the appropriate materials to return the products. If you have any questions regarding this notice, please call BridgePoint Medical, Vice President of Quality Assurance, at 763-225-8511 or e-mail at cschlawin@bridgepointmedical.com.

Root cause

Process control

Status

Terminated

Product code

DQY

Quantity affected

95 (57 USA, 38 OUS)

Distribution

Worldwide distribution: USA (nationwide) including: AL, AZ, CA, CO, GA, IL, KY, MD, MN, MO, NC, NY, OR, PA, WA, and WI; and countries of: Australia and Sweden.

Date initiated

2012-06-26

Date posted

2012-07-24

Date terminated

2012-09-06

Location

Minneapolis, MN

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