Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001.
Hazard
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
What You Should Do
Remedy
"U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.
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Products
Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001.
- Brand
- Disetronic Medical Systems, Inc.
- UPC
- Lots 31069UF, 31089UF, 3C097UF, 3D073UF, 3D129UF, 3E046UF, 3F010UF, 3F067UF, 3F068UF, 3F126UF, 3G007UF, 3G152UF, 3G172UF, 3H003UF, 3I145UF, 3J025UF, 3J183UF, 3K056UF, 3L052UF, 3L065UF, 4A088UF, 4C121UF, 4D097UF, 4D108UF, 4E084UF, 4E159UF, 4F097UF, 4F174UF, 4G101UF, 4H038UF, 4H112UF, 4I007UF, 4I161UF, 4I183UF, 4J116UF, 4K043UF, 4L045UF, 5C036UF, 5D185UF, 5E031UF, 5F158UF, 5F192UF, 5H136UF, 5I072UF, 5I120UF, 5J173UF, 5K005UF, 5K080UF, 5K105UF and 6B068UF.
Units Affected
546,530 in US and Canada plus 31,840 outside N. America