Z-2124-2026Class II
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-01-07 / Open, Classified / root cause: manufacturing process
Medline Industries, LP began a recall of Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005 on . FDA classified it as Class II and gives the reason as "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2124-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
- Product code
- KKX Drape, Surgical, Antimicrobial
- Reason for recall
- Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/14/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-
- Quantity in commerce
- 240 units
- Distribution
- Worldwide - US Nationwide distribution.
- Product codes and lots
- 1) DYNJ35363A, UDI-DI: 10884389516461(each), 40884389516462(case), Lot Number: 21BBP020; 2) SPTPCD10005, UDI-DI: 10080196228652(each), 40080196228653(case), Lot Number: 24JBB041
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2089-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2090-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2091-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2092-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2093-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2094-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2095-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2096-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2097-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2098-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2099-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2100-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2101-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2102-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2103-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2104-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2105-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2106-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2107-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2108-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2109-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2110-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2111-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2112-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2113-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2114-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2115-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2116-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2117-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2118-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2119-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2120-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2121-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2122-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2123-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2124-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2125-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2126-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2127-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2128-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2129-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2130-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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