Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastome
FDA device recall Z-0346-03 · posted 2002-12-18 · Terminated
Recall details
- Recalling firm
- SSL Americas Inc.
- Reason for recall
- Sulfur particles on the surface of gloves.
- Action taken
- On 11/25/2002 the Company representatives contacted the headquarter offices of the firm's in the U.S. by telephone and in writing by UPS delivery. On 11/26/2002 the Company sent the distributors' branches letters via UPS delivery. Approximately 1500 hospitals (customers of the Company's distributors) were notified by letter via UPS delivery. Customers were instructed to cease distribution of the suspected lot number gloves, contact their customers, and return any remaining gloves via UPS to the recalling firm. A response letter is attached to the recall letter. The Company intends to contact by telephone all of its direct accounts who do not respond to the Recall Letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- KGO
- Quantity affected
- 173,310 pairs
- Distribution
- Various Hospitals, Direct accounts,and Company sales representatives in: AL, AZ,, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MN, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA
- Date initiated
- 2002-11-25
- Date posted
- 2002-12-18
- Date terminated
- 2003-07-21
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE (K000421) | Ssl Americas, Inc. (Regent Medical) | 2000-08-14 |