ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico. Catalogue No: 800608-013 Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
This recall has been terminated (originally issued September 23, 2008).
- Company
- Acist Medical Systems
- Recall Initiated
- June 6, 2008
- Posted
- September 23, 2008
- Terminated
- January 25, 2011
- Recall Number
- Z-2406-2008
- Quantity
- 11,750 (USA), 22,230 (OUS)
- Firm Location
- Eden Prairie, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection.
Distribution
Worldwide Distribution --- USA including states AR, AZ, DC, FL, GA, MS, NC, NE, NH, NY, OH, OK, PA, TX, TN,VA, AL, CA, IL, KS, KY, LA, MD, MN, MO, SD, CO, IA, IN, MI, NV, PR, SC, MI, OR, WV, CT, ND, DC, WA, ME, and NJ, and countries of Canada, Brazil, Japan, China, Korea, Thailand, Hong Kong, and Australia.
Lot / Code Info
0368H, 0368J, 0378L, 0388F, 0388N, 0388V, 0498F, 0498H, 0508B, 0528P, 0528W, 0578N, 0588J, 0588K, 0598T, 0848K, 0848L, 0878M, and 0918N.
Root Cause
Package design/selection
Action Taken
Consignees were sent a "Urgent: Medical Device Recall" letter dated July 9. 2008. The letter addressed to "Manager" described the Proben and product. The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to stop further distribution of that product and immediately cease use of the product. The letter listed the applicable lots and asked customers to verify their inventory against the list. Any inventories matching the lots on the recall list were to be checked on the provided form and the quantity recorded. They were instructed to return the product to ACIST using the provided Air Bill number along with the form, signed and dated. The letters were sent July 10, 2008.