FDA Device recall Z-0995-2013
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in
- FDA Device
- Class II
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class II recall of KIMGUARD Container Filters, 7.5in (19cm), Round and 9in by Kimberly Clark, citing some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0995-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-06 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kimberly Clark |
| Distribution | AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI |
Product
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
Reason
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
Identifiers
| code_info | Product Code 68507 (Round) Case Lot Numbers MF1284XXX, MF1287XXX, MF1294XXX, MF1316XXX, MF2012XXX, MF2055XXX, MF2086XXX…Product Code 68507 (Round) Case Lot Numbers MF1284XXX, MF1287XXX, MF1294XXX, MF1316XXX, MF2012XXX, MF2055XXX, MF2086XXX, MF2098XXX, MF2115XXX, MF2146XXX, MF2178XXX, MF2188XXX, MF2196XXX, MF2210XXX, MF2228XXX, MF2243XXX, MF2264XXX, MF2271XXX, MF2285XXX, MF2328XXX, and MF2338XXX. Product Code 68509 (Square) Case Lot Numbers MF1279XXX, MF1287XXX, and MF1288XXX. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0995-2013%22
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