Unifine Pentips recallZ-0382-2018 · Owen Mumford USA, Inc. · initiated Nov 6, 2017

Why it was recalled

Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.

FDA root cause category: Environmental control

What the company is doing

Owen Mumford sent an Urgent Medical Device Recall Notification letter dated November 6, 2017 via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to check inventory for affected product, contact the Customer Service Department to arrange return of affected product, complete and return the response form and to either provide a customer list for Owen and Mumford to notify their customers or confirmation that they will notify their customers if further distributed.

Recall details

Recall number

Z-0382-2018

Status

Terminated

Initiated by the company

Nov 6, 2017

Recalling firm

Owen Mumford USA, Inc.

Quantity

708 cartons (21,240 pen needles)

Product code

FMI

FDA submissions

K152339

Distribution

US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV

Product description

Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Unifine Pentips AN 1150

  Owen Mumford USA Incorporated · Needle, Hypodermic, Single Lumen
  1 recall0 reports

Product lines

• Unifine PentipsOwen Mumford USA Incorporated · 5 models · 10 reports · 2 recalls

Other devices under the same FDA submission

17 devices cleared under K152339 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Unifine Pentips AN 3550

  Owen Mumford USA Incorporated · Needle, Hypodermic, Single Lumen
  1 recall2 reports
• Kroger AN 3540KRO

  Kroger CO., The · Needle, Hypodermic, Single Lumen
  6 reports
• Unifine Pentips Plus AN 3840

  Owen Mumford USA Incorporated · Needle, Hypodermic, Single Lumen
  6 reports
• Unifine Pentips AN 3540AC

  Owen Mumford USA Incorporated · Needle, Hypodermic, Single Lumen
  4 reports
• Unifine Pentips AN 3530

  Owen Mumford USA Incorporated · Needle, Hypodermic, Single Lumen
  3 reports
• Unifine Pentips Plus AN 3850

  Owen Mumford USA Incorporated · Needle, Hypodermic, Single Lumen
  3 reports
• Kroger AN 3550KRO

  Kroger CO., The · Needle, Hypodermic, Single Lumen
  2 reports
• Kroger AN 3590KRO

  Kroger CO., The · Needle, Hypodermic, Single Lumen
  2 reports
• Ahold - CareOne UPP 5mm pen needles AN 3850AH

  Ahold U.S.A., Inc. · Needle, Hypodermic, Single Lumen
  2 reports
• LEADER 4938494

  Cardinal Health 110, Inc. · Needle, hypodermic, single lumen
  2 reports
• Pentips AN 3430

  Owen Mumford USA Incorporated · Needle, Hypodermic, Single Lumen
  2 reports
• Pentips AN 3450

  Owen Mumford USA Incorporated · Needle, Hypodermic, Single Lumen
  2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 78483).

• Z-0381-2018 · Terminated
  Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of d…