FDA-Device2016-12-28Class II
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Teleflex Medical
Hazard
Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
Sold states
Nationwide Distribution to CA, CO, FL, GA, IL, KS, KY, MA, MO, MS, NC, NJ, NY, OH, OK, OR, PA and TX.
Affected count
102,843 units
Manufactured in
2917 Weck Dr, N/A, Research Triangle Park, NC, United States
Products
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0771-2017Don't want to check this manually?
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