Z-1197-2020Class II

EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04

Name: Z-1197-2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04
Creator: Arrow International Inc
Published: 2020-01-15
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2020-01-15 / Terminated

FDA source

Arrow International Inc began a recall of EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04 on 2020-01-15. FDA classified it as Class II and gives the reason as "There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1197-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-15
Posted: 2020-01-24
Terminated: 2023-03-17
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
FDA root cause: Other
Action: An Urgent Medical Device Recall notification letter dated 1/15/20 was sent to customers. Our records indicate you have received products that are subject to this field action. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately identify product, discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter.
Quantity in commerce: 343,105 total
Distribution: The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
Product codes and lots: Lots: 71F19B0678 71F19C1428 71F19E1149 71F19G0313 71F19J0072 71F19L0492 71F19B2751 71F19D0558 71F19E1781 71F19G2388 71F19J1370 71F19L0493 71F19C0778 71F19D2449 71F19F0737 71F19H1817 71F19K2849

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1197-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1170-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1171-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1172-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1173-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1174-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1175-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1176-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1177-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1178-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1179-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1180-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1181-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1182-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1183-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1184-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1185-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1186-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1187-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1188-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1189-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1190-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1191-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1192-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1193-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1194-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1195-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1196-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1197-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1198-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1199-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1200-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1201-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1202-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1203-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1204-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1205-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1206-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1207-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1208-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1209-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1210-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1211-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1212-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1213-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1214-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1215-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1216-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1217-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1218-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13

Product code CAZ

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)