Boca Medical Products, Inc. Issues
Nationwide Recall of Insulin Syringe Product
Contact: Marian Fernandez
1-800-354-8460
FOR IMMEDIATE RELEASE -- Coral Springs,
FL -- April 13, 2006 --- Boca Medical Products, Inc.,
of Coral Springs, Florida is initiating a recall of
3984 boxes of Ultilet Insulin Syringe 30g 1/2cc product
lot number 5GEXI as displayed on the inner case. The
product is being recalled because of possible bacterial
presence of Bacillus Cereus and Staphylococcus Intermedius.
This present a risk of local infection due to soft
tissue injection with a contaminated syringe as well
a risk of introduction of contaminating organism into
previously sterile vial. The introduced contamination
may degrade the insulin, which could lead to problems
maintaining insulin levels. Boca Medical continues
to evaluate possible risks.
Consumers who have Ultilet Syringe Insulin
product lot 5GEXI, should stop usage and return the
specific product. Wholesalers should stop retail and
return the product lot. Send the product to Boca Medical
Products Inc, 3550 NW 126 th Ave, Corals Springs,
FL 33065. Attention: Recall Contact. For any question
related to the case consumers should call 1-800-354-8460.
The recall include the following product:
Product Description - Ultilet
Insulin Syringe 30g ½ cc
Lot - 5GEXI
NDC # - 08326-3002-50
A single complaint and a reported event
prompted a Company investigation, which is on going.
The compliant stated that when the syringe was used,
the color of the insulin solution entering the syringe
chamber changed. The firm decision to recall the product
lot is voluntary. The firm has placed all inventory
of the product on hold. FDA has been apprised of this
action.
No serious injury has been reported.
No other lot is included on this Recall.
Boca Medical method of distribution
is through wholesalers. This product is sold by prescription
orders. This product has been distributed to the following
states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR.
Boca Medical is notifying its wholesalers
by fax and is arranging for the return of the recalled
product from retail and consumer level.
Consumers with questions including physicians
and pharmacists may contact Boca Medical at 1-800-354-8460.
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