Z-2630-2024Class II

Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack...

Name: Z-2630-2024 Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack...
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) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack 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-2630-2024
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) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028
Product code: PEV Dialysis Administration Kit
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: DYNDA2516B , Lot Number 23IBE112 ; DYNDA2516B , Lot Number 23JBH284 ; DYNDA2516B , Lot Number 23KBE900 ; DYNDA2516B , Lot Number 23LBO850 ; DYNJ36932A , Lot Number 23FBK320 ; DYNJ36932A , Lot Number 23GBU834 ; DYNJ36932A , Lot Number 23HBG572 ; DYNJ36932A , Lot Number 23LBL499 ; DYNJ58502C , Lot Number 21IMD970 ; DYNJ58502C , Lot Number 21KMA999 ; DYNJ910121 , Lot Number 24CDB254 ; PICCNC0028 , Lot Number 23KBL354

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2630-2024
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 PEV

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)