Z-1779-2022Class II

Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91

Name: Z-1779-2022 Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Creator: SunMed Holdings, LLC
Published: 2022-09-08
License: https://open.fda.gov/license/

Salter Labs / initiated 2022-09-08 / Terminated / root cause: manufacturing process

FDA source

SunMed Holdings, LLC began a recall of Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 on 2022-09-08. FDA classified it as Class II and gives the reason as "The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1779-2022
Classification: Class II
Status: Terminated
Initiated: 2022-09-08
Posted: 2022-09-23
Terminated: 2024-06-18
Recalling firm: Salter Labs
Product: Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Product code: CBT Arterial Blood Sampling Kit
Reason for recall: The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On September 8, 2022, the firm sent Urgent Medical Device Product Removal letters via email to affected customers. Customers were instructed to either return or destroy and discard affected product. If customers have further distributed the affected device, they should forward the notification to the receiving facility. Sun Med will provide new replacement product. If you have any questions regarding this field action, please call SunMed at 1-800-433-2797, or e-mail at [email protected].
Quantity in commerce: 53,560 units
Distribution: Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
Product codes and lots: UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1779-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1779-2022	Class II	Terminated	Voluntary: Firm initiated	2022-10-05	2022-09-23

Product code CBT

K944941Class IPiston SyringeMartell Medical Products, Inc. / cleared 1994-12-05

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)