Recalls / Class III
Class IIID-0489-2017
Product
Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, Rx only, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013, Reorder #6306, UPC 6 18029 83041 8.
- Affected lot / code info
- Lot 59123, Exp 11/13/17
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.
Recalling firm
- Firm
- Sage Products Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3909 3 Oaks Rd, N/A, Cary, Illinois 60013-1804
Distribution
- Quantity
- 640 kits
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-02-02
- FDA classified
- 2017-02-21
- Posted by FDA
- 2017-03-01
- Terminated
- 2018-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0489-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.