Z-1089-2023Class II

Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c...

Name: Z-1089-2023 Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-11-17
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-11-17 / Open, Classified / root cause: design

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR... on 2022-11-17. FDA classified it as Class II and gives the reason as "Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1089-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-17
Posted: 2023-02-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
Product code: MLS Labor And Delivery Kit
Reason for recall: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Root cause tag: design
FDA root cause: Device Design
Action: Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
Quantity in commerce: 194 cases (508 units)
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Product codes and lots: a. GYN LAPAROTOMY HARPER PACK-LF, Item Number: DYNJ0160684D, Case UDI/GTIN: 40193489205528, Unit UDI/GTIN: 10193489205527, Lot Number: 22JDA531,22IDB178,22IDA705; b. OB GYN LAP PACK-LF, Item Number: DYNJ43413C, Case UDI/GTIN: 40193489901185, Unit UDI/GTIN: 10193489901184, Lot Number: 22JBS296; c. VAGINAL HYSTERECTOMY PACK, Item Number: DYNJ47624B, Case UDI/GTIN: 40193489735360, Unit UDI/GTIN: 10193489735369, Lot Number: 22KBB429,22IBE503; d. DELTA PACK, Item Number: DYNJ59117A, Case UDI/GTIN: 40193489457897, Unit UDI/GTIN: 10193489457896, Lot Number: 22JMC869,22JMC852,22HMD762; e. MAJOR VAGINAL-LF, Item Number: DYNJ901807G, Case UDI/GTIN: 40193489814157, Unit UDI/GTIN: 10193489814156, Lot Number: 22IDC043; f. GYN LAPAROSCOPY II, Item Number: DYNJS2030D, Case UDI/GTIN: 40193489214148, Unit UDI/GTIN: 10193489214147, Lot Number: 22JDA984;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1089-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1060-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1061-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1062-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1063-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1064-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1065-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1066-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1067-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1068-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1069-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1070-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1071-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1072-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1073-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1074-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1075-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1076-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1077-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1078-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1079-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1080-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1081-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1082-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1083-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1084-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1085-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1086-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1087-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1088-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1089-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1090-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1091-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1092-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1093-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1094-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1095-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1096-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06
Z-1097-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06

Product code MLS

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)