EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455

FDA device recall Z-2672-2014 · posted 2014-09-22 · Terminated

Recall details

Recalling firm

Vidacare Corporation

Reason for recall

The voluntary recall is due to the needle set not meeting its specifications.

Action taken

Vidacare sent an Urgent Medical Device Recall Notification to all of its customers on March 31, 2014.The letter identified the product the problem and the action to be taken by the customers. The firm asked its customers to return the affected lot for a replacement. Customers were instructed: 1. If you have affected stock, immediately discontinue use and quarantine any product with the part number and lot number as identified above 2 To return product. complete the enclosed Medical Device Recall Acknowledgment and Return Response Form and fax it to 1 866-431-6194, Attn "Customer Service" This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Vidacare Corporation and to facilitate replacement product if one has not already been provided 3. If you have already used the affected stock. please complete the enclosed Medical Device Recall Acknowledgement and Return Response Form and fax it to 1-866-431- 6194, Attn" Customer Service". This will allow us to document your receipt of the letter. Vidacare Corporation is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-479-8500.

Root cause

Material/Component Contamination

Status

Terminated

Product code

FMI

Quantity affected

172

Distribution

Worldwide Distribution-US (nationwide) including the states of LA, NY, CA, CT, WA, AK, NJ, TX, GA, MI, MO, MD, FL, KY, VA, OH, UT, SC, NC, IN, AZ, MN, IL, TN, OK, KS, NE, MT, MS, AR, ID, WV and PA., a

Date initiated

2014-03-31

Date posted

2014-09-22

Date terminated

2015-01-30

Location

San Antonio, TX

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