Surgical convenience kits labeled as recallZ-1128-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Dec 7, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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."
Recall details
- Recall number
- Z-1128-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 7, 2022
- Posted by the FDA
- Feb 10, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 4779 units
- Product code
- OJH
- Distribution
- Nationwide
Product description
Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number SPEC0177; e) CENTURION MEDICAL PRODUCTS LUMBAR PUNCTURE KIT, Reorder Number PT235A
Code information (models, lots, serial numbers)
a) Reorder Number DYNJ67850, GTIN 10193489445541, Lot # 22BBJ239; b) Reorder Number DYNJSHOULDER2, GTIN 10884389097458, Lot # 22DBN344; c) Reorder Number P429589A, GTIN 40889942436348, Lot # 22HME367; d) Reorder Number SPEC0177, GTIN 40884389914657, Lot # 22MBA770; e) Reorder Number PT235A, GTIN 40653160992746, Lot # 22HMH321
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ67850Medline Industries, Inc. · Orthopedic tray1 recall0 reports
- Centurion Medical Products Corp PT235AMedline Industries, Inc. · Orthopedic tray1 recall0 reports
- Medline Industries, Inc. DYNJSHOULDER2Medline Industries, Inc. · Orthopedic tray1 recall0 reports
- Medline Industries, Inc. SPEC0177Medline Industries, Inc. · Orthopedic tray1 recall0 reports
- MEDLINE P429589ACenturion Medical Products Corporation · TRAY, SURGICAL1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 91483).
- Z-1109-2023 · Open, ClassifiedSurgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
- Z-1110-2023 · Open, ClassifiedSurgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691
- Z-1111-2023 · Open, ClassifiedSurgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
- Z-1114-2023 · Open, ClassifiedSurgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
- Z-1118-2023 · Open, ClassifiedSurgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENT…
- Z-1119-2023 · Open, ClassifiedSurgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number…
- Z-1120-2023 · Open, ClassifiedSurgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
- Z-1122-2023 · Open, ClassifiedSurgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
- Z-1123-2023 · Open, ClassifiedSurgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
- Z-1124-2023 · Open, ClassifiedSurgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT…
- Z-1125-2023 · Open, ClassifiedSurgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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