Z-1848-2020Class I

Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm...

Name: Z-1848-2020 Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm...
Creator: Applied Medical Resources Corp
Published: 2019-10-24
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2019-10-24 / Terminated

FDA source

Applied Medical Resources Corp began a recall of Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175 on 2019-10-24. FDA classified it as Class I and gives the reason as "The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1848-2020
Classification: Class I
Status: Terminated
Initiated: 2019-10-24
Posted: 2020-05-07
Terminated: 2023-06-01
Recalling firm: Applied Medical Resources Corp
Product: Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
Product code: DXE Catheter, Embolectomy
Reason for recall: The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
FDA root cause: Component change control
Action: On November 08, 2019, a "Urgent: Medical Device Recall" letter was sent via UPS to all affected customers. In addition to providing information on the recalled products, the letter asked customers to do the following: 1. Check your inventory for the recalled product. 2. Complete the Recall Notification Confirmation Form to acknowledge the recall and indicate if your facility is returning or has already used product from the lot listed above. 3. If no product is being returned, please indicate on the Recall Notification Confirmation Form. 4. If you are a distributor, please notify any facilities to which you distributed the affected product. Please also complete Page 4 of the Recall Notification Confirmation Form. 5. Return the Recall Notification Confirmation Form to Applied Medical by email to [email protected] or faxing it to (949) 713-8908. 6. Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical (Product Return Instructions are on Page 5). 7. For product return questions, please contact Jaclene Rios-Simpson, Senior Manager, Customer Relations at (949) 713-8688 or [email protected]. 8. For regulatory questions, please contact me, Lauren Contursi, at (949) 713-8767 or [email protected].
Quantity in commerce: 28,799 catheters in total
Distribution: Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom
Product codes and lots: Model A4GW6, Applied Medical DUAL LUMEN GRAFT CLEANING CATETER, 9mm X 60cm, lot numbers 1267676, 1272322, 1284680, 1295323, 1306127, 1312586, 1330450, 1334826, 1338738, 1339555

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1848-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1846-2020	Class I	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-07
Z-1847-2020	Class I	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-07
Z-1848-2020	Class I	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-07

Product code DXE

K973465Class IILatis Graft Cleaning CatheterApplied Medical Resources / cleared 1998-02-19

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)