Device Recall Forteo teriparatide (rDNA origin) injection starter kits 의 리콜

Recall

58219

Class 2

Z-2191-2011

2011-03-17

2011-05-12

Terminated

United States

2011-08-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98738

Eli lilly and company announced 3/17/2011 that patients should not use the alcohol prep pads made by the triad group that are contained in the black starter kits for forteo [teriparatide (rdna origin) injection] in the united states.The tri-ad group is recalling the alcohol prep pads due to potential contamination with the bacteria, ba-cillus cereus, which could result in life threatening infecti.

The firm, Eli Lilly and Company, sent two letters entitled "URGENT MEDICAL DEVICE RECALL TRIAD GROUP ALCOHOL PREP PADS INCLUDED IN FORTEO STARTER KITS ALL ALCOHOL PREP PAD LOTS" to its customers. The first letter was dated March 18, 2011 and second follow-up letter was dated March 28, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to examine their inventory of Forteo starter kits; if they have any Forteo starter kits with a black bag, remove and appropriately discard the Triad Group alcohol prep pads; discontinue providing the product with the starter kits; inform any patients that may have received Forteo starter kits containing the Triad Group alcohol prep pads to discontinue use; note: after removing the Triad Group alcohol prep pads, all other components of the Forteo starter kits are acceptable for use: travel bag, pen case, gel packs, needles and instructional materials, and complete and return the enclosed business reply card. "It is important to note that this recall does not affect or involve the Forteo delivery device." For questions pertaining to the recall, contact Triad Group at 262-538-2900. (Please refer to the Triad Group press release issued on January 5, 2011 on the FDA website.) If you have product specific medical questions related to Forteo please call 1-800-LILLYRX.