FDA Recalls

The FDA has issued recalls on epinephrine auto-injectors and
HeartStart
FR2+ AEDs.  Brief information is below.  For complete information, go
to
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm237050.htm

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PRODUCT
1) Twinject®(epinephrine injection, USP, 1:1000) auto-injector 0.3 mg,
Two Pack, Rx only, For Subcutaneous or Intramuscular Use Only, NDC:
59630-802-02. Recall # D-109-2011;

2) Epinephrine injection, USP, auto-injector 0.3 mg, Rx only, For
Subcutaneous or Intramuscular Use Only; NDC: 59762-0171-1.. Recall #
D-110-2011;

3) Epinephrine injection, USP, auto-injector 0.3 mg, Two-Pack, Rx
only,
For Subcutaneous or Intramuscular Use Only; NDC: 59762-0171-2. Recall
#
D-111-2011
CODE
1) Lot Number: U100701B, Expiry Date: 12/11;
2) Lot Number: G100702W, Expiry Date: 12/11;
3) Lot Number: G100801X, Expiry Date: 11/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shionogi Pharma, Inc., Atlanta, GA, by letter on/about
October 28, 2010.
Manufacturers: Hospira, Inc., McPherson, KS;Covidien LP, Deland, FL;
Phillips Plastics Corp, Phillips Medical, Menomonie, WI. Firm
initiated
recall is ongoing.
REASON
Lack of Assurance of Sterility: Possibility exists a small number of
sheaths covering the needle may have pinholes.
VOLUME OF PRODUCT IN COMMERCE
34,629 units
DISTRIBUTION
Nationwide



PRODUCT
1) HeartStart FR2+ AEDwith ECG Display, Model M3860, Philips brand,
configurable manual charge in advance mode. The label of the device
states: "HEARTSTART...FR2+ Automated External Defibrillator. Recall #
Z-0483-2011;

2) HeartStart FR2+ AEDwith Text Display (No ECG), Model M3861, Philips
brand, no configurable manual charge. The label of the device states:
"HEARTSTART...FR2+ Automated External Defibrillator. Recall #
Z-0484-2011;

3) HeartStart FR2+ AEDwith ECG Display, Model 3840, Laerdal brand,
configurable manual charge in advance mode. The label of the device
states: "HEARTSTART...FR2+ Automated External Defibrillator. Recall #
Z-0485-2011;

4) HeartStart FR2+ AEDwith Text Display (No ECG), Model 3841, Laerdal
brand, no configurable manual charge. The label of the device states:
"HEARTSTART...FR2+ Automated External Defibrillator. Recall #
Z-0486-2011;

5) HeartStart FR2+ AEDwith ECG Display, Model 989803148601. This
product is G2005 Update according to the American Heart Association
2005
Guidelines for Cardiopulmonary Resuscitation and Emergency
Cardiovascular Care (ECC). The label of the device states:
"HEARTSTART...FR2+ Automated External Defibrillator. Recall #
Z-0487-2011;

6) HeartStart FR2+ AEDwith Text Display, Model 989803148611. This
product is G2005 Update in accordance with the American Heart
Association 2005 Guidelines for Cardiopulmonary Resuscitation and
Emergency Cardiovascular Care (ECC). The label of the device states:
"HEARTSTART...FR2+ Automated External Defibrillator. Recall #
Z-0488-2011
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Seattle, WA, by letters beginning October 5,
2010. Firm initiated recall is ongoing.
REASON
A flash memory component in the HeartStart FR2+ and Automated External
Defibrillator was improperly relabeled by a third party. Therefore the
component could not be identified by its source, quality, and date of
manufacture.
VOLUME OF PRODUCT IN COMMERCE
27, 270 units (7393 units Nationwide and 19877 units Internationally)
DISTRIBUTION
Nationwide and International


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