Z-2213-2021Class II
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model...
Stryker Medical / initiated 2021-05-12 / Open, Classified / root cause: labeling and UDI
Stryker Medical Division of Stryker Corporation began a recall of IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999 on . FDA classified it as Class II and gives the reason as "Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-2213-2021
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Stryker Medical
- Product
- IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
- Product code
- IKY Mattress, Flotation Therapy, Non-Powered
- Reason for recall
- Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
- Root cause tag
- labeling and UDI
- FDA root cause
- Under Investigation by firm
- Action
- Stryker notified users/consumers via written notification Urgent Medical Device Removal letter notified via FedEx on Friday, June 18, 2021. In addition, customers may be contacted by phone or email. International distribution divisions were notified by validated electronic system (Trackwise) on May 13, 2021. Letter states reason for recall, health risk and action to take: Customers are instructed to: 1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number). 2. If you are using the product in a home, Stryker recommends that you discontinue use of the product. 3. Complete and sign the enclosed business reply form. a. Return this signed letter by fax (269) 488-8691or email [email protected] to Stryker's Regulatory Department. 1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number). 2. If you are using the product in a home, Stryker recommends that you discontinue use of the product. 3. Complete and sign the enclosed business reply form. a. Return this signed letter by fax 269 488 8691 or email [email protected] to Strykers Regulatory Department. 4. Upon receipt of the signed business reply form, Stryker will contact you to arrange the removal of your product(s) if applicable. If you have any questions or concerns, contact us at +1 269 389 8306 or [email protected]. We apologize for any disruption this may cause.
- Quantity in commerce
- 3 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
- Product codes and lots
- Serial Numbers: 031528600216109 051428600212599 081328600206460 UDI: 07613327298512
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2205-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2206-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2207-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2208-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2209-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2210-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2211-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2212-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2213-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2214-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2215-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2216-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2217-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2218-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2219-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2220-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2221-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2222-2021 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2223-2021 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.