Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot #
FDA device recall Z-1924-2016 · posted 2016-06-07 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- This recall has been initiated due to the product labeled with the incorrect expiration date.
- Action taken
- MedComp sent a Product Recall letter dated May 5, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to evaluate their inventory and quarantine for the return of all un-used affected product. They were asked to contact Customer Service for a Return Goods Authorization (RGA) number at 215-256-9191.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).
- Distribution
- US Distributed to: FL, TX, NC
- Date initiated
- 2016-05-05
- Date posted
- 2016-06-07
- Date terminated
- 2017-06-16
- Location
- Harleysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER (K130687) | Medical Components, Inc. | 2013-08-15 |