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Old 06-19-2009, 11:26 AM
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Exclamation Diabetes Related Recalls

http://www.fda.gov/downloads/Safety/.../UCM167873.pdf

FDA Enforcement Report June 17, 2009 Page 345

NIPRO Disposable Insulin Syringe 1cc 29G X 1/2", U-40 Insulin, Single Use, Reorder No. JD+01U2913-40, Vetierinary Use Only, Not For Human Use, Latex Free, Packaging is 1 case/30 boxes/10 pouches/10 syringes (resulting in 3000 pieces per case). UPC 383791940015 (pouch), 383791940107 (box), 3383791940315 (case). Recall #V-209-2009.

CODE
Lot No. 20071026; Expiration Date 20101025 (October 25, 2010)


RECALLING FIRM
Nipro Medical Corporation, Miami, FL, by telephone, email and letter on May 22, 2009
MANUFACTURER Nipro Corporation, Osaka, Japan. Firm initiated recall is ongoing.

REASON
Insulin syringes, for animal use, size 0.05 cc were packed into pouches, boxes and cases labeled as 1.0 cc, which could result in incorrect dose of insulin.


VOLUME OF PRODUCT IN COMMERCE
87 cases/30 boxes/10 pouches of 10 syringes each (261,000 units)

DISTRIBUTION
OHIO