Recall Z-0386-2019— Becton Dickinson & Company

Name: FDA recall Z-0386-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-26

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2018-09-26, terminated 2020-04-13. It names one FDA 510(k) clearance: K811885. Product: PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module directions for Use for complete loading and operating instructions. Notes: The set should be changed according to the facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.. Reason: The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2018-09-26
Terminated: 2020-04-13
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K811885 — 30-30-2 700 SYRINGE EXTENSION SETY·cleared 1981-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module directions for Use for complete loading and operating instructions. Notes: The set should be changed according to the facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

Reason for recall

The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.