Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Bemis/ Medline

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Bemis/ Medlinesee related information
Date Initiated by FirmAugust 23, 2006
Date PostedNovember 16, 2006
Recall Status1 Terminated 3 on January 04, 2007
Recall NumberZ-0170-2007
Recall Event ID 36160
510(K)NumberK931664 K941664 
Product Classification sharps container - Product Code MMK
Product5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers; Made in USA for: Medline Industries; BEMIS label has Manufactured by Bemis Mtg. Co., Sheboygan Falls, WI.
Code Information BEMIS: Model 7H150 020 includes lot 20060001 to 20060016;  BEMiS: Model 7H150 030 includes lot 20050006, 20060001 to 20060008;  BEMIS: Model 7H150 040 includes lot 20060001 to 20060008;  Medline Model 7H950 030 includes lot 20050027, 20060001 to 20060008.
Recalling Firm/
Manufacturer		 Bemis Health Care,Inc
300 Mill St
Sheboygan Falls WI 53085-1807
For Additional Information ContactNancy Steinpreis
920-467-5464
Manufacturer Reason
for Recall		The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container.
FDA Determined
Cause 2		Other
ActionLetters were mailed to consignees August 23, 2006 describing the product with lots and model numbers. Customers were asked to have product destroyed rather than returned to Bemis. Enclosed with the letter was a Recall Acknowledgement/Destroy in field form that they were instructed to fax to BEMIS. A second letter was sent out to the non-responders on September 13, 2005.
Quantity in Commerce145,656 Units
DistributionNationwide and Canada.
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.
510(K) Database510(K)s with Product Code = MMK
-
-