Z-2632-2024Class II

Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number...

Name: Z-2632-2024 Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-04-08
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number... on 2024-04-08. FDA classified it as Class II and gives the reason as "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2632-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-08
Posted: 2024-08-27
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445; 5) CENTRAL LINE INSERTION KIT W/20CM CATH, Part Number ECVC7445A; 6) VANTEX 7FR 3L 20CM CVC BUNDLE US, Part Number ECVC8045; 7) CVC DOUBLE LUMEN 16CM, Part Number ECVC8105
Product code: LRP Tray, Surgical
Reason for recall: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
Quantity in commerce: 1,679,067 units in total
Distribution: Worldwide distribution.
Product codes and lots: DYNDA1431A, Lot Number 2019021190; ECVC3260, Lot Number 2019091850; ECVC3260, Lot Number 2019120950; ECVC7440, Lot Number 2021071950; ECVC7440, Lot Number 2021092150; ECVC7445, Lot Number 2021052850; ECVC7445, Lot Number 2021062250; ECVC7445A, Lot Number 2022012850; ECVC7445A, Lot Number 2023010390; ECVC8045, Lot Number 2023031590; ECVC8105, Lot Number 2023112190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2632-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2623-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2624-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2625-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2626-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2627-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2628-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2629-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2630-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2631-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2632-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2633-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2634-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28
Z-2635-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-28

Product code LRP

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)