Z-1128-2023Class II

Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER...

Name: Z-1128-2023 Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-12-07
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-12-07 / Open, Classified / root cause: sterility

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c)... on 2022-12-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1128-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-07
Posted: 2023-02-10
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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
Product code: OJH Orthopedic Tray
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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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."
Quantity in commerce: 4779 units
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1128-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1109-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1110-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1111-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1112-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1113-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1114-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1115-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1116-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1117-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1118-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1119-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1120-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1121-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1122-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1123-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1124-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1125-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1126-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1127-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1128-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)