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AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm)… recallZ-0574-2010 · Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals · initiated Oct 27, 2009

Terminated All recalls posted in December 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Needles are becoming dislodged from the barrels.

FDA root cause category: Other

What the company is doing

The recall is being conducted to the Consumer level. A Press Release was issued on October 27, 2009 stating that Qualitest Pharmaceuticals was issuing a nationwide recall of all Accusure Insulin Syringes. The consignees were asked to post a copy of the press release in their retail stores and to alert patients of this action. Also, Recall Notifications were sent to all of the firm's consignees by First Class Mail on October 30, 2009. The consignees were instructed to notify their customers or sub accounts who may have been sold or dispensed the affected syringes starting in 2002, and to return the affected product. Questions are directed to the firm at telephone number 800-444-4011.

Recall details

Recall number
Z-0574-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 27, 2009
Posted by the FDA
Dec 28, 2009
Recalling firm
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Quantity
171,421 cartons of 100
Product code
FMF
FDA submissions
K021197, K080904, K993017
Distribution
Nationwide

Product description

AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21

Code information (models, lots, serial numbers)

all lots

Other devices under the same FDA submission

15 devices cleared under K021197, K080904, K993017 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 53709).

Sources and updates

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