Z-1983-2020Class II

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI /...

Name: Z-1983-2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI /...
Creator: Access Scientific LLC
Published: 2020-04-23
License: https://open.fda.gov/license/

Access Scientific, Inc. / initiated 2020-04-23 / Terminated / root cause: packaging

FDA source

Access Scientific LLC began a recall of BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access... on 2020-04-23. FDA classified it as Class II and gives the reason as "Saline Flush Syringe compromised sterility due to holes in the packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1983-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-23
Posted: 2020-05-14
Terminated: 2021-04-27
Recalling firm: Access Scientific, Inc.
Product: BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
Product code: FMF Syringe, Piston
Reason for recall: Saline Flush Syringe compromised sterility due to holes in the packaging.
Root cause tag: packaging
FDA root cause: Packaging
Action: Customer Service Department will send the Advisory Notice and Recall Response Form to all affected levels of the distribution chain. On 04/23/2020, the firm sent an Urgent: Medical Device Recall letter to heir distributors and hospitals requesting them to discard all BD PosiFlush" SF Saline Flush Syringe 10 ml (part number 306553) from the convenience kits.
Quantity in commerce: 110 units
Distribution: US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA.
Product codes and lots: LOTS: 267011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1983-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1972-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1973-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1974-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1975-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1976-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1977-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1978-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1979-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1980-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1981-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1982-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1983-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14

Product code FMF

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)