Agency classClass IIOur severity:High FDA (Devices)·Z-1981-2020·Announced 2020-05-20

Access Scientific Recalls Pediatric Saline Flush Syringes Due to Packaging Holes

Access Scientific LLC is recalling 120 units of BD PosiFlush SF Saline Flush Syringes used in pediatric kits because holes in the packaging compromised sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves compromised sterility in a medical device used for vascular access, which poses a risk of infection, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Access Scientific LLC is recalling 120 units of the BD PosiFlush SF Saline Flush Syringe 10 mL, which is used in the POWERWAND XL 3Fr 6cm Pediatric Kit. The recall is due to holes in the packaging that compromised the sterility of the syringes. The affected lots are 257867, 259519, and 264750.

The product is used to gain access to the vascular system to sample blood and administer fluids intravenously, and may be used for power injection of contrast media. The recall covers US nationwide distribution, including specific states such as 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, and UT.

Healthcare providers and consumers should stop using the affected syringes immediately. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - 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…
Manufacturer: Access Scientific LLC
Category: Medical Device — Syringes
Hazard: sterility-compromise
infection-risk
Affected units: 120

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

LOTS: 257867
259519
264750

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 12 recalled by Access Scientific LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Same manufacturer · Access Scientific LLC

See all →

Low
Access Scientific Recalls Mislabeled Powerwand XL Maximum Barrier Kits
FDA (Devices) · 2020-07-22
High
Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
High
Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
High
Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects
FDA (Devices) · 2020-05-20
High
Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20

Same hazard · sterility compromise