Recall Class: Class I
Date Recall Initiated: January 10, 2014
Products: t:slim Insulin Cartridges, Specific Lots, Used with the t:slim Insulin Pump
Affected Lot Numbers:
M001963 M001980 M002027 M002083 M002119 M001964 M001987 M002028 M002096 M002120 M001973 M001988 M002029 M002097 M001974 M001990 M002030 M002099 M001979 M001991 M002082 M002100 M000857 M001414 M001454 M000869 M001415 M001455 M001344 M001416 M001456 M001345 M001417 M001457 M001346 M001420 M001458 M001347 M001421 M001459 M001389 M001422 M001460 M001390 M001423 M001528 M001391 M001451 M001529 M001392 M001452 M001530 M001393 M001453 M001532
Other cartridge lots and the t:slim Insulin Pump are NOT affected by this recall.
The affected cartridges were distributed from December 17, 2013 through January 6, 2014.
Use: An insulin pump is used to deliver insulin directly under the skin to manage diabetes in people requiring insulin; for individuals 12 years of age and greater.
Tandem Diabetes Care, Inc.
11045 Roselle Street, Suite 200
San Diego, California 92121
Reason for Recall: The affected cartridges may be at risk for leaking. A cartridge leak could potentially result in the delivery of too much or too little insulin, which could lead to unexpected high or low blood glucose levels. Too much insulin can result in severe low blood sugar (hypoglycemia) and too little insulin can lead to severe high blood sugar (hyperglycemia), both of which can lead to serious injury or death.
Public Contact: To obtain replacement cartridges at no charge, call Tandem Technical Support at 1-877-801-6901, available 24 hours a day, 7 days a week. Also call this number for instructions and pre-paid packaging to return unused cartridges affected by this recall.
FDA District: Los Angeles District Office
FDA Comments: On January 10, 2014, Tandem Diabetes Care (or Tandem) began notifying customers by overnight mail and by email of an Urgent Medical Device Voluntary Recall for specific lots of insulin cartridges used with the t:slim Insulin Pump, noting that the affected cartridges may be at risk for leaking.
Customers who received affected cartridges are being contacted by the company or its authorized distributors and are asked to call Tandem Technical Support to receive cartridges at no charge. Tandem Diabetes Care asked customers to return all unused cartridges from the affected lots to Tandem.
On January 20, 2014, Tandem Diabetes Care sent an updated URGENT MEDICAL DEVICE VOLUNTARY RECALL letter. The firm expanded its voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump. All affected lot numbers are listed above.
Consumers/Patients: What Should You Do?
- Check the lot numbers of your cartridge supply against the complete list of affected lot numbers above. You can find the cartridge lot number on the rear panel of the cartridge box and on the packaging of each individual cartridge.
- Look at the photograph of the cartridge box in the Urgent Medical Device Voluntary Recall letter that shows where the lot number is found. The affected cartridges cannot be identified by inspecting the cartridges themselves.
- STOP using cartridges affected by this recall. If you don’t have useable cartridges, discontinue the pump and revert to your backup plan until new supplies arrive.
- Call Tandem Technical Support at 1-877-801-6901, 24 hours a day, 7 days a week to receive replacement cartridges at no charge if you are affected by this recall. Also call Tandem to receive instructions and pre-paid packaging to return unused cartridges affected by this recall.
- Read the Frequently Asked Questions in the firm’s Urgent Medical Device Voluntary Recall letter.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.