| | Class 2 Recall
ULTRA Fabric Reinforced surgical Gown X-Large Sterile |  |
| Date Posted |
November 07, 2012 |
| Recall Number |
Z-0257-2013 |
| Product |
ULTRA Fabric Reinforced surgical Gown X-Large Sterile
The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. |
| Code Information |
Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146***
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Recalling Firm/
Manufacturer |
Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell, Georgia 30076 |
| For Additional Information Contact |
Thomas Kozma, PhD
770-587-7835
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Reason for
Recall |
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
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| Action |
Kimberly Clark sent an Urgent Voluntary Product Recall letter dated July 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to determine if they have any affected product in their inventory. Any affected product should be quarantined and distribution discontinued. Distributors were also asked to conduct a sub-recall for any affected product further distributed. Customers were asked to complete the attached Distributor Product Recall Response Form and fax to 1-920-225-3522. Upon completion of the response form customers were asked to destroy any affected product.
For questions regarding this recall call 770-587-7835. |
| Quantity in Commerce |
89,856 (28 units per case) |
| Distribution |
Nationwide Distribution |
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