Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glov
FDA device recall Z-0162-2018 · posted 2017-11-21 · Terminated
Recall details
- Recalling firm
- Medline Industries Inc
- Reason for recall
- Possible open seal on top portion of the package. Could cause breach of sterility.
- Action taken
- Medline Industries sent an Immediate Action Required Letter dated October 23, 2017, to all affected customers.. Instructions included to check inventory and quarantine affected product, complete and return the response form to Medline, arrange for the return of any affected product, and notify any customers if the product was further distributed. Customers with questions were instructed to call 866-359-1704.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- KGO
- Quantity affected
- 8,000 units
- Distribution
- Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX,
- Date initiated
- 2017-10-23
- Date posted
- 2017-11-21
- Date terminated
- 2021-04-06
- Location
- Northfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR (K040503) | Wrp Asia Pacific Sdn. Bhd. | 2004-03-16 |