This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
The FDA is aware that AVID Medical has issued letters to affected customers recommending certain Organ Recovery OR Packs and Medical Convenience kits be corrected prior to continued use.
Affected devices:
| Device Name | Kit Code | Kit Lot Number | Unique Device Identifier (UDI) |
|---|---|---|---|
| Organ Recovery OR Pack | LLOG1000-15 | 1632138 | 10809160432679 |
| Organ Recovery OR Pack | LLOG1000-15 | 1648393 | 10809160432679 |
| Organ Recovery OR Pack | LLOF1000-17 | 1651709 | 10809160460726 |
| Mini Plus Kit South | JACK097-08 | 1654185 | 10809160462829 |
What to Do
Do not use the Poly bags in affected kits, as they are not medical grade Poly and are not suitable for organ transport. Add warning labels to affected kits to ensure the component is discarded and not used. The other components in the affected kits may continue to be used.
On November 11, AVID Medical sent affected customers a medical device recall notification. On November 17, AVID Medical sent an additional letter recommending the following actions:
- Be aware that the 24x30 Poly bags included in the kits are not medical grade poly and are not suitable for organ transport.
- Segregate and quarantine all impacted product remaining in inventory.
- Discontinue use of the 24x30 Poly bag included in the affected kits.
- Add warning labels to affected kits to ensure the component is discarded.
- A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling.
- Customers: If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.
- Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.
Reason for Correction
AVID Medical stated that the 24x30 Poly bags included in the Organ Recovery Packs are not medical grade poly and are not suitable for organ transplant. In addition, the plastic bags may not be sealed on the bottom. The compromised integrity of the bag could result in a lack of containment of the donor organ during use. AVID Medical has reported a lack of containment instance.
Use of the affected product may increase the risk of post-transplant infections, organ failure due to compromised viability, exposure to toxic substances from non-medical grade materials, and need for additional medical interventions or re-transplantation. Allogenic transplant operations may be delayed or cancelled due to donor organ loss, damage, or contamination.
Non-medical grade plastics may contain toxic additives, plasticizers, or heavy metals and leachable substances could migrate into preservation solutions and organ tissues. Chemical exposure may cause organ toxicity or adverse reactions in transplant recipients. Use of a kit with compromised sterility could lead to sepsis, organ rejection, or transmission of infectious diseases to recipients.
As of December 18, AVID Medical has reported one MDR for loss of containment and has not reported any serious injuries or deaths associated with this issue.
Device Use
Organ Recovery Packs are kits containing various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact AVID Medical at complaints@owens-minor.com.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
