Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
Class I - DangerousWhat Should You Do?
- Check if you have this product: All unexpired lots: C003699 C003715 C003735 C003750 C003775 C003804 C003813 C003842 C003853 C003887 C003905 C003936 C003950 C003960 C003966 C003986 C003997 C004028 C004041 C004078 C004091 C004107 C004117 C004128 C004136 C004160 C004186 C004206 C004221 GTIN 08714729848097
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
Product Codes/Lot Numbers:
All unexpired lots: C003699 C003715 C003735 C003750 C003775 C003804 C003813 C003842 C003853 C003887 C003905 C003936 C003950 C003960 C003966 C003986 C003997 C004028 C004041 C004078 C004091 C004107 C004117 C004128 C004136 C004160 C004186 C004206 C004221 GTIN 08714729848097
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1490-2021
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