Specific lots of insulin cartridges used with the t:slim Insulin Pump have been recalled because the cartridges are at risk for leaking, causing the delivery of too much or too little insulin, a serious life-threatening event. Consumers should discontinue using insulin cartridges labeled with the affected lots.
The affected insulin cartridges were shipped on or after December 17, 2013 and represent approximately 4,746 boxes of cartridges (10 cartridges per box). The affected insulin cartridge Lot Numbers are:
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
If you have any of the affected cartridges call Tandem to receive replacement cartridges at no charge. Tandem Customer Support is available 24 hours a day, 7 days a week at 1-877-801-6901.
Read the MedWatch Safety Alert, including links to the Press Release
The Food & Drug Administration (‘FDA”) would like you to report any adverse events or side effects from the use of the t:slim insulin cartridges to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
At Terrell • Hogan, we protect consumers’ health.