CLASS I Device recall · Reported 10 Sep 2014 · FDA Enforcement Report

Cysto Tur Pack, convenience pack include multiple recalled by Customed

Customed is recalling Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, distributed nationwide in the US. The recall was initiated on 20 May 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct code 900-080, 37 lots: 109061259 109071681 109091967 109102245 109122679 110020427 110040863 110061419 110081951 111030731 111040866 111061577 111071877 111082180 111092575 111102818 111123295 111123409 111123475 112010012 112020300 112072820 112083049 112093839 112124910 113057408 113078229 113088827 113099264 131110145 131210670 140111082 140211626 140311911 140412449 140513057 140613558

Quantity recalled37 lots, 2360 units (multiple units per lot)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2306-2014
FDA event ID: 68536
Recalling firm: Customed, Fajardo, PR
Classification: Class I
Status: Terminated
Recall initiated: 20 May 2014
FDA classified: 29 Aug 2014
Reported: 10 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

20 May 2014	Recall initiated by company
29 Aug 2014	Classified by FDA	+101 days
10 Sep 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

Where it was distributed

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

Nationwide Florida Puerto Rico

Questions about this recall

Is Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape recalled?

Yes. Customed recalled Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape on 20 May 2014. The recall is Class I and its status is Terminated. Recall number Z-2306-2014.

Why was it recalled?

Which lots are affected?

Product code 900-080, 37 lots: 109061259 109071681 109091967 109102245 109122679 110020427 110040863 110061419 110081951 111030731 111040866 111061577 111071877 111082180 111092575 111102818 111123295 111123409 111123475 112010012 112020300 112072820 112083049 112093839 112124910 113057408 113078229 113088827 113099264 131110145 131210670 140111082 140211626 140311911 140412449 140513057 140613558

Where was it sold?

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Customed

All 682

Reported	Class	Recall	Company	Reason	Where
20 Apr 2016Device	CLASS II	Catalog Number: 900277 Suction Catheter Tray 14FR With Sodium recalled	Customed	Sterility	PR
20 Apr 2016Device	CLASS II	Catalog Number: 9002940 Obstetrical Surgical Pack Used by medical recalled	Customed	Sterility	PR
20 Apr 2016Device	CLASS II	Catalog Number: 900010 Suture Removal KIT Used by medical staff to recalled	Customed	Sterility	PR
20 Apr 2016Device	CLASS II	Catalog Number: 9001933 Ophtalmic Surgical Pack Used recalled	Customed	Sterility	PR
20 Apr 2016Device	CLASS II	Catalog Number: 900169 Universal Surgical Pack Used by medical staff recalled	Customed	Sterility	PR

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide