Recalls / —
—#170558
Product
Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent.
- FDA product code
- NAB — Gauze / Sponge,Nonresorbable For External Use
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Lot Number: 18E190262 Expiration Date: 05/2023
Why it was recalled
Curity All Purpose Sponges were not sterilized and distributed
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Cardinal Health issued Urgent: Medical Device Recall dated 12/27/18 advising of the problem and action to take: inspect segregate and return product. Return the acknowledgment form.The letter provides instructions to direct consignees to notify customers. Questions contact Cardinal Health at 800-292-9332
Recalling firm
- Firm
- Cardinal Health
- Address
- 200 LLC 15 Hampshire St, Bldg 5, Mansfield, Massachusetts 02048-1113
Distribution
- Distribution pattern
- Worldwide distribution - US Nationwide and countries of Canada, Colombia.
Timeline
- Recall initiated
- 2018-12-27
- Terminated
- 2020-06-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #170558. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.