CLASS II Device recall · Reported 20 Apr 2016 · FDA Enforcement Report
Catalog Number: 9001460 Reyito Plus Urology Surgical Pack Used recalled
Customed is recalling Catalog Number: 9001460 Reyito Plus Urology Surgical Pack Used by, distributed in Puerto Rico. The recall was initiated on 7 Jan 2016 and the FDA has classified it as Class II.
Check your package
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-1425-2016
- FDA event ID
- 72992
- Recalling firm
- Customed, Fajardo, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jan 2016
- FDA classified
- 14 Apr 2016
- Reported
- 20 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 7 Jan 2016 | Recall initiated by company | |
| 14 Apr 2016 | Classified by FDA | +98 days |
| 20 Apr 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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
Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it was distributed
Distributed only in Puerto Rico.
Stores named: Walmart
Questions about this recall
Is Catalog Number: 9001460 Reyito Plus Urology Surgical Pack Used by recalled?
Yes. Customed recalled Catalog Number: 9001460 Reyito Plus Urology Surgical Pack Used by on 7 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-1425-2016.
Why was it recalled?
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Which lots are affected?
LOTS: SL15202 (150619550) 30-JUN-16 SL15202 (150619235) 30-JUN-16 SL15209 (150719642) 31-JUL-16 SL15209 (150619550) 30-JUN-16
Where was it sold?
Distributed only in Puerto Rico.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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| Device | CLASS II | Catalog Number: 900277 Suction Catheter Tray 14FR With Sodium recalled | Customed | Sterility | PR |
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| Device | CLASS II | Catalog Number: 900169 Universal Surgical Pack Used by medical staff recalled | Customed | Sterility | PR |
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