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U.S. Department of Health and Human Services

Class 1 Device Recall One Touch

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 Class 1 Device Recall One Touchsee related information
Date Initiated by FirmFebruary 02, 2007
Date PostedMarch 03, 2007
Recall Status1 Terminated 3 on June 08, 2007
Recall NumberZ-0547-2007
Recall Event ID 37307
Product Classification Blood Glucose Test Strips - Product Code NBW
ProductOne Touch Basic/Profile and One Touch Ultra-Blood Glucose Test strips- 50-count
Code Information One Touch Ultra Test Strips: Lot #''s: 2691191, 2691261. One Touch Ultra Basic/Profile Test Strips- Lot #''s 272894A, 2619932, 2606340, 2651211.
FEI Number 3003894406
Recalling Firm/
Manufacturer		 Safety & Supplies Co. Inc.
17 Edgeboro Rd
East Brunswick NJ 08816-1600
For Additional Information ContactAhmed Anjum
732-698-1600
Manufacturer Reason
for Recall		Counterfeit product (manufacturer unknown)
FDA Determined
Cause 2		Other
ActionA recall notification was sent on February 1, 2007 via first class mail to all customers.
Quantity in CommerceUnknown
DistributionNationwide to pharmacies.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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