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U.S. Department of Health and Human Services

Class 2 Device Recall Broselow/Hinkle Pediatric Emergency System

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  Class 2 Device Recall Broselow/Hinkle Pediatric Emergency System see related information
Date Initiated by Firm April 26, 2011
Date Posted June 29, 2011
Recall Status1 Terminated 3 on January 14, 2013
Recall Number Z-2704-2011
Recall Event ID 58857
Product Classification Mask, oxygen - Product Code BYG
Product Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA
The kit contains oxygen masks and blood pressure cuffs use on pediatric patients
Code Information Expiration for kit is four years.   Oz Masks  #D075986 Class I Exempt Device  If you have purchased directly from Vital Signs, the product codes affected are: 7700BAW2, 7700GAW2, 7700OAW2, 7700PAW2, 7700RAW2, 7700WAW2, 7700YAW2, Kits with masks included: 7730ALS, 7730BLU5, 7730FLY, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5. If you have purchased directly from Armstrong Medical, the Product Codes affected are: AE-4700

 AE-4712, AE-4701, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, 7730GRN, 7700RAW, 7700PAW, 7700YAW, 7700WAW, 7700BAW, 7700OAW, 7700GAW " Lot numbers of the affected modules are: 2009 K109 through K365 2010 P001 through P149510 (k) : K781055; Medical Device Listing   Blood Pressure Cuffs  If you have purchased directly from Vital Signs, the product codes affected are: BP4030BR, BP4530BR, 7730POCH, 7730IALS If you have purchased directly from Armstrong Medical, the product codes affected are: AE-4703, AE- 4700, AE-4706, AE-4707 " Lot numbers affected are: For the year 2009 LOT Number 2689 through LOT Number 3659 For the year 2010 LOT Number 0010 through LOT Number 2530 Any lot number that ends in the number 1 is NOT affected by the recall.
Recalling Firm/
Manufacturer		 Vital Signs Devices, a GE Healthcare Company
20 Campus Rd
Totowa NJ 07512-1210
For Additional Information Contact Ms. Gwen Braeger
262-548-2608
Manufacturer Reason
for Recall		 Broselow Pediatric Emergency System Kit may contain oxygen masks that may contain a potentially sticky substance on the inside and/or outside of the mask.
FDA Determined
Cause 2		 Other
Action GE issued an URGENT MEDICAL DEVICE CORRECTION letter dated April 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the affected product, isolate all affected product, complete the attached confirmation form and fax back per the instructions and return any unused product. For any product forwarded to any other healthcare institution, customers were instructed to forward a copy of the URGENT MEDICAL DEVICE CORRECTION letter to those institutions. For any questions contact Vital Signs Customer Service at 1-800-932-0760.
Quantity in Commerce 33,002 units
Distribution IL
Total Product Life Cycle TPLC 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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