Recall Z-1116-2023
MEDLINE INDUSTRIES, LP - Northfield · initiated December 7, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489
Codes / lots: GTIN 41093489695366, Lot # 22BMH128
Reason for recall
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
FDA-determined cause: Under Investigation by firm
Action taken
The firm sent a correction notice to its direct consignees on 12/07/2022 by US mail and email. The notice explained the issue and requested the following: "Please check you stock for affected kits and over-labeling will be sent to place on kits to ensure that all labeling is accurate. No kits are to be returned back to Medline. All components are not affected. Our records indicate that these were used as a component in the list of kit(s) purchased from Medline Industries, LP." "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. Have the customers return any affected product to you for collection and return to Medline Industries, LP." "If you have any questions, please contact the Recall Department at 866-359-1704."
Details
- Recall number
- Z-1116-2023
- Initiated
- December 7, 2022
- Posted by FDA
- February 10, 2023
- Product code
- FTN – Plastic Surgery And Accessories Kit
- Quantity
- 480 units
- Distribution
- Nationwide
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1109-2023 Class II | Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122AThe recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1110-2023 Class II | Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1111-2023 Class II | Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1112-2023 Class II | Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1113-2023 Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1114-2023 Class II | Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224BThe recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1115-2023 Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1117-2023 Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1118-2023 Class II | Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1119-2023 Class II | Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1120-2023 Class II | Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1121-2023 Class II | Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641AThe recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1122-2023 Class II | Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1123-2023 Class II | Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643AThe recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1124-2023 Class II | Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1125-2023 Class II | Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1126-2023 Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1127-2023 Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |
| Z-1128-2023 Class II | Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b)…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | 12/07/2022Open, Classified |