Recall Z-0720-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated November 6, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8) ENT HUTCH, SKU DYNJ58856A; 9) PACK NASAL, SKU DYNJ60111A; 10) PACK NASAL, SKU DYNJ60111B; 11) ENT CUSTOM PACK, SKU DYNJ63052C; 12) ENT PACK, SKU DYNJ64256D; 13) FESS/SEPTOPLASTY PACK, SKU DYNJ64509B; 14) SINUS ENDOSCOPY PACK, SKU DYNJ65644; 15) ACOUSTICS SHSC-LF, SKU DYNJ66749; 16) TRANSPHENOIDAL PACK, SKU DYNJ67423A; 17) TRANSPHENOIDAL PACK, SKU DYNJ67423B; 18) ENT PACK, SKU DYNJ68102B; 19) E N T PACK, SKU DYNJ80526B; 20) NASAL PACK, SKU DYNJ81280; 21) ENT FESS PACK, SKU DYNJ81420A; 22) HEAD AND NECK PACK, SKU DYNJ81934; 23) HEAD AND NECK PACK - 51597, SKU DYNJ81934A; 24) HEAD AND NECK ENT PACK, SKU DYNJ83679A; 25) HEAD NECK PACK HC, SKU DYNJ84270; 26) TRANSPHENOIDAL PACK-LF, SKU DYNJ85422; 27) NASAL SEPTAL, SKU DYNJ901299A; 28) NASAL SEPTAL, SKU DYNJ901299B; 29) PACK TRANSPHENOIDAL, SKU DYNJ905685D; 30) SEPTOPLASTY, SKU DYNJ906474C; 31) LEFORTE MANDIBLE, SKU DYNJ906839A; 32) NASAL MHS, SKU DYNJ908545A; 33) NASAL MHS, SKU DYNJ908545B; 34) ENT, SKU DYNJ909128A; 35) ENT, SKU DYNJ909128C; 36) ENT, SKU DYNJ909128D; 37) ENT, SKU DYNJ909128F; 38) SINUS PACK, SKU DYNJ909370
Codes / lots: UDI-DI: CDS982901F, 10889942216970 (each), 40889942216971 (case), Lot Numbers: 23HBQ152; UDI-DI: DYNJ17493G, 10195327224424 (each), 40195327224425 (case), Lot Numbers: 23GBW775; UDI-DI: DYNJ33520A, 10884389851333 (each), 40884389851334 (case), Lot Numbers: 23HDB834; UDI-DI: DYNJ44845G, 10889942712311 (each), 40889942712312 (case), Lot Numbers: 23HBF195; UDI-DI: DYNJ48330B, 10195327113506 (each), 40195327113507 (case), Lot Numbers: 23HBO622; UDI-DI: DYNJ50572, 10889942008476 (each), 40889942008477 (case), Lot Numbers: 23GBR940; UDI-DI: DYNJ53573A, 10193489201635 (each), 40193489201636 (case), Lot Numbers: 23GBS356; UDI-DI: DYNJ58856A, 10193489750263 (each), 40193489750264 (case), Lot Numbers: 23HBO870; UDI-DI: DYNJ60111A, 10193489246995 (each), 40193489246996 (case), Lot Numbers: 21JMB783 21HMF433 21GMD178 21FMC923 20IMB575; UDI-DI: DYNJ60111B, 10195327527617 (each), 40195327527618 (case), Lot Numbers: 24HMC974 24GMA899 24FMB079 24EMC108 24DMD791 24CMG320; UDI-DI: DYNJ63052C, 10195327101312 (each), 40195327101313 (case), Lot Numbers: 22KME394 22KMA630 22JMD852 22GMG160 22EMG974 22DMF954 22CMC565; UDI-DI: DYNJ64256D, 10195327452773 (each), 40195327452774 (case), Lot Numbers:…
Reason for recall
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
FDA-determined cause: Nonconforming Material/Component
Action taken
An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 11/7/24 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. Quarantine all affected product immediately. 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.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 the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-209-FGX1 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. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-0720-2025
- Initiated
- November 6, 2024
- Posted by FDA
- December 20, 2024
- Product code
- OGR – Ear, Nose, And Throat Surgical Tray
- Quantity
- 6467 kits
- Distribution
- US Nationwide. Canada.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0717-2025 Class II | MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0718-2025 Class II | FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0719-2025 Class II | DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0721-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0722-2025 Class II | SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0723-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0724-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0725-2025 Class II | KIT,SPINE LH Convenience kit, SKU DYNJ906448A.Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0726-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |