EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition directly into th
FDA device recall Z-2236-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG
- Action taken
- Boston Scientific notified customers by priority Express Mail on June 17, 2008. The notification instructs accounts to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 16 Kits (total number of Kits)
- Distribution
- NJ, SC, TN, VA, and WI
- Date initiated
- 2008-06-17
- Date posted
- 2008-09-17
- Date terminated
- 2008-12-10
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT (K030855) | Boston Scientific Corp | 2003-04-17 |