Recall Z-1607-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated March 3, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
Codes / lots: 1) DYNJCD0339, UDI-DI: 10195327483753(each), 40195327483754(case), Lot Number: 24KBK055
Reason for recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
FDA-determined cause: Under Investigation by firm
Action taken
An IMMEDIATE ACTION REQUIRED MEDLINE DEVICE RECALL notification letter dated 3/3/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 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 response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-050-FG Recall Code: RECALL CODE 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 request that customers document and destroy any affected product, and include your customer s quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-1607-2025
- Initiated
- March 3, 2025
- Posted by FDA
- April 17, 2025
- Product code
- FQM – Bandage, Elastic
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1586-2025 Class II | Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1587-2025 Class II | Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1588-2025 Class II | Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1589-2025 Class II | Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1590-2025 Class II | Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1591-2025 Class II | Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1592-2025 Class II | Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1593-2025 Class II | Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1594-2025 Class II | Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1595-2025 Class II | Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1596-2025 Class II | Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1597-2025 Class II | Medline Convenience kits used for various procedures: 1) T A PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1598-2025 Class II | Refer to RESThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1599-2025 Class II | Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1600-2025 Class II | Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1601-2025 Class II | Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1602-2025 Class II | Refer to RESThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1603-2025 Class II | Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1604-2025 Class II | Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1605-2025 Class II | Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1606-2025 Class II | Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1608-2025 Class II | Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1609-2025 Class II | Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1610-2025 Class II | Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1611-2025 Class II | Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1612-2025 Class II | Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1613-2025 Class II | Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1614-2025 Class II | Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1615-2025 Class II | Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |
| Z-1616-2025 Class II | Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | 03/03/2025Open, Classified |