FDA Recalls & Court
Actions
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March 15,
2006
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CLASS
II
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Auto
Syringe AS40 and AS40A Infusion
Pump
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Product code
1M8565 (pumps with drug library option) and product
codes 1M8560 and 1M8560R (pumps without drug library
option), All serial numbers.
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Manufacturer:
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Baxter
Healthcare Corp., Singapore.
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Recalled
by:
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Baxter
Healthcare Corp., Round Lake, IL, by letters dated Feb.
8, 2006. Firm-initiated recall is ongoing.
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Distribution:
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Nationwide
and Canada; 17,400 pumps were distributed.
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Reason:
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The occlusion
detection and alarm may be delayed when the pumps are
used with larger-volume syringes at low flow
rates.
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Recall
number:
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Z-0599-06.
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Easypump ST 100-1 Infusion Pump;
Easypump L T 60-24 Infusion Pump
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(a) Lot #
562791; (b) Lot # 562857.
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Manufacturer:
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I-Flow
Corporation, Lake Forest, CA.
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Recalled
by:
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Manufacturer,
by letter dated Jan. 17, 2006. Firm-initiated recall is
ongoing.
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Distribution:
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France; 1,179
units were distributed.
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Reason:
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The sterile
pack may contain the wrong infusion pump inside.
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Recall
numbers:
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Z-0584/0585-06.
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LifeCare PCA3 Infusion System
Software
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Versions 4.08
and 4.09, List numbers 12384-04, software version 4.08
and 4.09.
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Manufacturer:
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Hospira,
Inc., Morgan Hill, CA.
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Recalled
by:
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Manufacturer,
by letters on Nov. 2, 2005. Firm-initiated recall is
ongoing.
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Distribution:
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Nationwide;
10,489 units were distributed.
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Reason:
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Incorrect
values for dosage, dose limit, concentration or rate of
delivery may display on screen.
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Recall
number:
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Z-0601-06.
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MaxLock Screwdriver
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Part MXS-056.
This is a surgical instrument used in conjunction with
the MaxLock Plate and Screw System, Lot # 11298.
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Manufacturer:
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Troy
Innovative Instruments, Inc., Garrettsville, OH.
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Recalled
by:
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Orthohelix
Surgical Designs, Inc., Akron, OH, by telephone and
visits between Nov. 1 and 7, 2005. Firm-initiated
recall is ongoing.
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Distribution:
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OH, MO, TX,
SD, CO, NJ, GA and FL; 14 instruments were
distributed.
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Reason:
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Screwdriver
pilot taper tip can break during surgery.
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Recall
number:
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Z-0598-06.
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Natural
Hip System Collarless Stem, porous, with HA
coating
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For
cementless use only, Zimmer brand, sterile, Size 3,
Right; Ref 7356-02-103, Lot # 1648124.
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Manufacturer:
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Zimmer Inc.,
Warsaw, IN.
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Recalled
by:
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Manufacturer,
by email on Feb. 22, 2006. Firm-initiated recall is
ongoing.
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Distribution:
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AR, WI and
Australia; 5 units were distributed.
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Reason:
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Misbranded,
the package actually contains an APR hip system, HA
porous stem, 12 mm, left.
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Recall
number:
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Z-0597-06.
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Zilver
635 Biliary Stent - Expanding Stent
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Delivery
system length 80 cm, stent diameter 8.0 mm, stent
length 40 mm, minimum guiding catheter 8.0 French,
minimum sheath 6.0 French, recommended wire guide
size.035 inch dia., sterile; Catalog # ZIB6-80-8.0-40,
Lot # 1557057.
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Manufacturer:
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Cook, Inc.,
Bloomington, IN.
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Recalled
by:
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Manufacturer,
by telephone and fax on Jan. 26, 2006. Firm-initiated
recall is ongoing.
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Distribution:
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CA, PA, UT
and Canada; 5 stents were distributed.
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Reason:
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The side of
the boxes gives incorrect sizes for these stents. The
label front is correct.
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Recall
number:
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Z-0600-06.
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CLASS
III
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Thermoplastic templates
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(a) Single
tooth, Catalog Number 040.526; (b) free-end situation,
Catalog Number 040.527, (a) Lot # A2283; (b) Lot #
A2284.
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Manufacturer:
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Institut
Straumann, AG, Basel, Switzerland.
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Recalled
by:
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Straumann
Manufacturing Inc., Andover, MA, by letter dated Jan.
30, 2006. Firm-initiated recall is ongoing.
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Distribution:
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Nationwide;
138 units were distributed.
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Reason:
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Pilot drills
may not fully extend through drill guide in template
products.
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Recall
numbers:
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Z-0602/0603-06.
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EDITORS' NOTE:
Tabulation prepared from information provided by
FDA. The agency has three classes of recalls. Class
I - violative product poses reasonable probability
of serious adverse health consequences or death;
Class II - violative product may cause temporary or
medically reversible adverse health consequences;
probability of serious consequences remote; Class
III - violative product not likely to cause adverse
health consequences. Editors of "The Gray Sheet"
appreciate hearing from any company that would like to
provide additional information on any recall listed in
a weekly tabulation.
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