T:slim Insulin Delivery System Insulin Infusion Pump

FDA device recall Z-0827-2014 · posted 2014-02-10 · Terminated

Recall details

Recalling firm

Tandem Diabetes Care Inc

Reason for recall

Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

Action taken

Tandem Diabetes Care sent an Urgent Medical Device Voluntary Recall letter dated January 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check the lot numbers of their cartridge supply against the llist of affected lot numbers. Do Not use any cartridges from the lots affected by this recall. If customers don't have useable cartridges, discontinue using the pump and revert to their backup plan until new supplies arrive. Customers were instructed to call Tandem Technical Support at 1-877-801-6901 to receive replacement cartridges at no charge. Customers were asked to return the enclosed return response form via email, fax, or mail. UPDATED: Tandem Diabetes Care expanded the recall om January 20, 2014. Tandem Diabetes Care, Inc. (NASDAQ: TNDM), or Tandem, today announced that it is expanding a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump. For questions regarding this recall calll 858-366-6900, ext 6963.

Root cause

Equipment maintenance

Status

Terminated

Product code

LZG

Quantity affected

12, 807 boxes (10packs)

Distribution

USA (nationwide)

Date initiated

2014-01-10

Date posted

2014-02-10

Date terminated

2014-09-23

Location

San Diego, CA

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