Egyptian Drug Authority · Egypt
DEA-EG-2021-0005
Tier 1 · Regulator-publishedUnclassifiedRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no.(5) For 2021
- Date issued
- 08 Feb 2021
- Recorded by us
- 2026-09-06 19:49:24 UTC
- Product
- Covidien Endo GIA Autosuture universal articulating loading unit
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- Not published with the notice
- Expiry dates
- Not published with the notice
- Action type
- Recall
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Not stated by the issuing authority
- Product type
- Not stated by the issuing authority
- ATC code
- Not stated by the issuing authority
- Affected markets
- Egypt — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Notice text
- ARAB REPUBLIC OF EGYPT جمصوريه مصر العرييه EGYPTIAN DRUG AUTHORITY i dynnll الدواء a ism CA OF OPERATIONS 2 enn x الإدارة المركزية للعمليات po « ءا . LTT GA OF FACTORY INSPECTION 2 Ay .ع التمتيش علئ المصائع MEDICAL DEVICE INSPECTION nua > المستلزمات ¢ ale إدارة التفتيش أ 2021 dud )0( منشور دورى رقم نههافضطة.................. del] السيد الدكتور / وكيل الوزاره للشمُون ” ادارة الصيدلة ” .... تحيه طيبه وبعد وتحريز ما يوجد بالسوق المصري بعد اتخاذ كافة الاجراءات المخزنية و نلك dar io برجاء : للتشفيلة الواردة من المستلزم الطبي الآتي بياناته T8KO075X 232/2010/1 030455 Covidien Endo GIA Autosuture universal articulating loading unit CovidienlIC ,USA: 5 g3latl المصنع United States of America:laie بلد اسم طالب التسجيل: غليو نجي للتجارة. الصيدلية: Ale HIF يتاء" على سبب التحريز الآتي و الذي تم افادتنا به من الإدارة المركزية The purpose of this letter is to advise you that Medtronic is voluntary recalling specific production lots of its Covidian Endo GIA Auto suture universal articulating loading units .(item codes 030450,030451, 030452, 030453, 030454, 030455, 030457, 0304518) Issue Description: This voluntary recall is being conducted following receipt of one confirmed customer report that | the device staples were not properly formed upon application preventing adequate hemostasis. J Our investigation identified a potential for a manufacturing assembly error that can contribute > to a staple malformation. The affected devices were distributed between June 2017&July ا 2020.Use of a product with this assembly error may result in incomplete staple formation. / o In thoracoscopic/ laparoscopic cases, this could cause significant hemorrhage including A J hemothorax & hemoperitoneum potentially requiring an urgent conversion to open surgery. The potential also exists for bleeding ,anastomotic leak, pneumothorax or other delayed secondary complications including infection, peritonitis, sepsis, and an increased risk of mortality .Manufacturing process improvements have been implemented to remediate this issue. مع تسليم متندوب الشركة الأحراز بعد أخن التعهد اللازم بعدم فض الأختام إلا فى وجود مفتشى هيئة الدواء المصرية وتفضلوا بقبول واقر الاحترام»؛؛ wi مدير إدارة التفتيش على المستلزمات الطبية د. رباب بهنساوي الإدارة | للعمليا ak ol ps B4la ‘4 EE اميا الدواء المحسرهيم رئيس الإدارة المرزب Be ii AO على المصانع = د. يس يه Soild WLS) Cll 0 0 www.edaegypt.gov.eg (eo SLRS] 1 من 1 Eick & 15301 wa >Original language: ar
- Notice text in English
- Not translated. Only the authority's own words above are held.
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 1
Where this record came from, and what is held to show it.
- Copy of the source
- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.Ask us for it and check it against the fingerprint below.
- Fingerprint
- 54e2edc5722e1284da08b7d6c49ea9ab83342ecaa7a4b6edfcd9ee896946cbb9SHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
- Copy taken
- 2026-09-06 20:34:37 UTC
Cite this record
Drug Eye Africa (2021). DEA-EG-2021-0005: Covidien Endo GIA Autosuture universal articulating loading unit — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2021/dea-eg-2021-0005Version history
—No version history recorded for this record.
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.
Verification
Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.
Indexing
This record is indexable: it is dated, names a product, and carries either a batch number or a stated reason.