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U.S. Department of Health and Human Services

Class 2 Device Recall Powdered Surgical Glvoes

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  Class 2 Device Recall Powdered Surgical Glvoes see related information
Date Initiated by Firm December 28, 2016
Create Date November 14, 2018
Recall Status1 Terminated 3 on November 14, 2018
Recall Number Z-0456-2019
Recall Event ID 80754
Product Classification Surgeon's gloves - Product Code KGO
Product Powdered Surgical Gloves, labeled as:

a. Baxter and Ansell brand Powdered Surgical Gloves
b. Powdered Surgical Gloves included in ACS surgical convenience kits

Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.
Code Information Tray Number (Powdered Glove code): MHCE23D (ANS5711104), MHAP41D (ANS7825), MHOC43C (ANS7825), MHPO42D (ANS7825), GVTH071 (ANS5711104), GVTK05L (ANS5711104), GVTK05M (ANS5711104), CXTR68D (ANS5711105), MDEY35H (BAX2D7202I), MDEY35I (BAX2D7202I), FHLV24 (ANS5711105, ANS5711101), LKCA02A (ANS5710503), WIDE32 (ANS7824), UTLU70F (ANS7825), FIOH02H (BAX2D7254)
Recalling Firm/
Manufacturer		 American Contract Systems, Inc.
2610 Ne Industrial Dr Ste 220
Kansas City MO 64117-2648
For Additional Information Contact
816-920-5846
Manufacturer Reason
for Recall		 Powdered Surgical Gloves are an FDA banned substance.
FDA Determined
Cause 2		 Other
Action The firm, ACS, notified Customers via phone call and email on about 12/28/2016. The customers were informed about the product, problem and actions to be taken. The customers were instructed to identify and remove all the affected kits for replacement of the recalled gloves; tray insert label must reflect the omission of the powered gloves; and ban, quarantine and return affected product. If you have any questions, contact that Quality Manager at 816-920-5846 or email to: tbakke@amconsys.com.
Quantity in Commerce 1,180 kits
Distribution US Distribution to states of: IL, MO, NE, and OH.
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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