Ultracell Wick with 80cc Collection Bag, 20/box
FDA device recall Z-1199-2023 · posted 2023-03-01 · Open, Classified
Recall details
- Recalling firm
- Beaver Visitec International, Inc.
- Reason for recall
- Device packaging may contain open seals, compromising product sterility.
- Action taken
- A consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to beavervisitec8978@sedgwick.com.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HOZ
- Quantity affected
- 4640 units in total
- Distribution
- US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa
- Date initiated
- 2022-12-20
- Date posted
- 2023-03-01
- Location
- Waltham, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPHTHALMIC SPONGES (K920354) | Ultracell Medical Technologies, Inc. | 1992-08-05 |